DESC:FIELD OF INVENTION:
The present invention relates to a herbal composition comprising extracts of baby corn silk and/or baby corn husk. The present invention further provides process for preparing the extracts of baby corn silk and baby corn husk. The herbal composition is useful for management and prevention of diabetes, obesity, and cancer.

BACKGROUND OF INVENTION:
The increasing prevalence of chronic diseases such as diabetes, obesity, and cancer has spurred significant interest in natural products with potential therapeutic benefits. Baby corn silk (Zea mays L.), traditionally used in folk medicine, has emerged as a promising source of bioactive compounds due to its diverse pharmacological properties, including antioxidant, anti-inflammatory, and diuretic effects. Modern scientific studies have further substantiated the medicinal potential of baby corn silk, revealing its efficacy in managing metabolic disorders and chronic diseases.

Plants and herbs provide a natural source of chemotherapeutic drugs for the prevention or treatment of numerous illnesses. Herbs, which have been used for ages to cure a variety of ailments, play an important part in shaping the foundation of contemporary medicine. Furthermore, there is a growing need for organic materials used as food additives, functional food ingredients, nutraceuticals, and disease prevention. Modern scientific approaches may be used to assess the usefulness and benefits of indigenous plant materials for humanity. In this regard, one of such plant products is maize silk (Stigma maydis).

Baby corn silk (Zea mays L.) has long been valued in traditional folk medicine for its wide range of health benefits, including its well-documented antioxidant, anti-inflammatory, and diuretic properties. These properties have made it a common remedy for various ailments in several cultures. The therapeutic potential of baby corn silk is largely attributed to its rich content of bioactive compounds, including flavonoids, polyphenols, and polysaccharides. Recent scientific research has further supported these traditional uses, revealing that these bioactive compounds have significant potential in managing and treating modern health conditions such as diabetes, obesity, and cardiovascular diseases.

Corn silk, the yellowish thread-like strands from the female flower of maize, is a waste byproduct from corn agriculture and is abundant. Corn silk has long been used as a traditional medicine to treat gout, diabetes, nephrolithiasis, and inflammatory conditions. Corn silk's bioactive components offer several benefits, making it a promising natural product for healthcare. Corn silk's pharmacological effects include antioxidant, anti-inflammatory, diuretic, anti-diabetic, antibacterial, antifungal, anticancer, and anti-obesity properties due to its bioactive components.

However, conventional extraction methods often fall short in efficiently isolating these compounds, which can lead to lower yields and reduced bioactivity and stability of the extracts. To fully harness the therapeutic potential of baby corn silk, there is a pressing need to explore and implement advanced extraction techniques that can enhance the efficiency, yield, and quality of the extracts.

Baby corn husk extract is derived from the outer covering of baby corn (Zea mays L.), which is a byproduct of corn cultivation. It has garnered attention for its pharmacological benefits due to its rich content of bioactive compounds.

The present invention focuses on developing a novel process for extracting bioactive compounds from baby corn silk and husk individual or both in combination by using techniques such as ethanolic extraction, hydro-ethanolic extraction, aqueous extraction, supercritical fluid extraction (SFE), ultrasonic-assisted extraction (UAE), and microwave-assisted extraction (MAE). These methods are optimized to maximize the yield and stability of bioactive compounds, ensuring their safety and efficacy for various therapeutic applications.

The present inventors felt that there is a need to provide herbal composition comprising baby corn silk extract and/or baby corn husk extract optionally in combination with Trigonella Foenum-Graecum (Fenugreek), Syzygium Cumini (Jamun), Berberis Aristata (Daruharidra), Aegle Marmelos (Bael), Ocimum Sanctum (Tulsi), Cinnamon, Gymnema Sylvestre, and Momordica Charantia (Bitter Melon) for targeting multiple pathways associated with diabetes, obesity, and cancer. This remains the objective of the present invention.

OBJECT OF THE INVENTION:
An object of the present invention is to provide a novel herbal composition of the extracts of baby corn silk and/or husk and to the process of prep thereof. optionally in combination with other herbs.

Another object of the present invention is to provide extraction methods to preserve and concentrate the bioactive compounds/extracts from baby corn silk and baby corn husk, ensuring their maximum therapeutic potential.

SUMMARY OF INVENTION:

In line with the above objective, in an aspect, the present invention provides a novel herbal composition comprising extracts of baby corn silk in an amount in the range of 1.2 to 75 %, baby corn husk in an amount in the range of 1.2 to 75 %, either alone or in combination thereof.

In another aspect, the present invention provides a novel herbal composition comprising extracts of baby corn silk in an amount in of 30 %, baby corn husk in an amount of 14 %, either alone or in combination thereof.

In another aspect, the present invention provides a novel herbal composition for management and prevention of diabetes, obesity, and cancer wherein said composition comprises extracts of baby corn silk and baby corn husk.

In yet another aspect, the herbal composition of the present invention may comprise additional extracts of herbs selected from:
i. Trigonella Foenum-Graecum (Fenugreek) extract in an amount in the range of 1.2 to 75 %, more preferably 18 %;
ii. Syzygium Cumini (Jamun) extract in an amount in the range of 0.5 to 30 %, more preferably 4.8 %;
iii. Berberis Aristata (Indian Barberry); extract in an amount in the range of 1.2 to 50 %, more preferably 18 %;
iv. Aegle Marmelos (Bael) extract in an amount in the range of 1.2 to 50 %, more preferably 24 %;
v. Ocimum Sanctum (Holy Basil or Tulsi) ) extract in an amount in the range of 1.5 to 45 %, more preferably 23.1 %;
vi. Cinnamomum Verum (True Cinnamon) extract in an amount in the range of 0.5 to 35 %, more preferably 4 %;
vii. Gymnema Sylvestre extract in an amount in the range of 0.5 to 35 %, more preferably 7 %;
viii. Momordica Charantia (Bitter Melon) extract in an amount in the range of 0.5 to 35 %, more preferably 10 %;
ix. Curcuma Longa (Turmeric) extract in an amount in the range of 0.5 to 35 %, more preferably 6 %;
x. Pterocarpus Marsupium extract in an amount in the range of 0.5 to 35 %, more preferably 8 %;
xi. Moringa Oleifera extract in an amount in the range of 0.5 to 35 %, more preferably 4.2 %;
xii. Tinospora Cardifolia (Guduchi or Giloy) extract in an amount in the range of 1.2 to 30 %, more preferably 6 %;
xiii. Neem Leaf (Azadirachta indica) extract in an amount in the range of 0.5 to 35 %, more preferably 16 %;
xiv. Andrographis Paniculata (Kalmegh) extract in an amount in the range of 1.5 to 40 %, more preferably 8 %; and
xv. Piper Longum (Long Pepper) extract in an amount in the range of 0.01 to 30 %, more preferably 1.2 %.

In another aspect, the herbal composition may comprises of acceptable excipients or additives selected from binders, diluents, surfactants, emulsifiers, carriers, lubricants, solvents, pH adjusters, colorants, essential oils, anti-caking agent, dispersing agent and the like, alone or mixtures thereof.

In another aspect, the present invention provides a novel process for extracting bioactive compounds from baby corn silk using extraction techniques, including ethanolic extraction, hydro-ethanolic extraction, aqueous extraction, supercritical fluid extraction (SFE), ultrasonic-assisted extraction (UAE), and microwave-assisted extraction (MAE).

Accordingly, in an aspect, the extracts of baby corn silk and baby corn husk may be obtained by ethanolic extraction process comprising the steps of :
a) Ethanolic Extraction Process:
i. Collecting the fresh baby corn silk and baby corn husk from mature corn plants; ensuring the materials are clean and free from contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or impurities followed by drying the cleaned materials using air-drying or a low-temperature drying process to reduce moisture content while preserving bioactive compounds;
iii. Grinding the dried silk and husk into a coarse powder to enhance the surface area for extraction;
iv. Preparing a 70% to 90% concentrated ethanol solution based on the desired extraction efficiency;
v. Extracting individually by utilizing each product as obtained in step iii:
1. Baby Corn Silk: Combining the powdered baby corn silk with ethanol in an extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v); and
2. Baby Corn Husk: Mixing the powdered husk with ethanol in a separate extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
vi. Extracting by combining baby corn silk and baby corn husk in step (iii) by of step (a):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with ethanol and maintaining a solvent-to-material ratio of 5:1 to 10:1 (v/v);
2. Stirring continuously or agitating the mixture as obtained in step (1) of step (vi) to promote effective extraction of bioactive compounds; and
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a duration of 4 to 24 hours, depending on the efficiency required;
vii. Filtering the mixture as obtained in step (v) and (vi) using filter paper or a centrifuge to separate the liquid extract from the solid residues;
viii. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
ix. Purifying the concentrated extract as obtained in step (viii) using techniques such as column chromatography or high-performance liquid chromatography (HPLC) to isolate specific bioactive compounds; and
x. Drying the purified extract as obtained in step (ix) to obtain a stable powder or concentrated liquid suitable for various applications.

In another aspect, the extracts of baby corn silk and baby corn husk may be obtained by hydro-ethanolic extraction method comprising the steps of:
b) Hydro-Ethanolic Extraction Method:
i. Obtaining fresh baby corn silk and baby corn husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing a hydro-ethanolic solvent by mixing water and a 30% to 70% concentrated ethanol solution based on the desired extraction efficiency;
vi. Extracting individually by utilizing each product as obtained in step iv:
1. Baby Corn Silk: Combining the powdered baby corn silk with the hydro-ethanolic solvent in an extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
2. Baby Corn Husk: Mixing the powdered husk with the hydro-ethanolic solvent in a separate extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
vii. Extracting by combining each product obtained in step (iv) of step (b):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the hydro-ethanolic solvent and maintaining a solvent-to-material ratio of 5:1 to 10:1 (v/v);
2. Stirring continuously or agitating the mixture to enhance the extraction of bioactive compounds;
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a period of 4 to 24 hours depending on the efficiency of extraction;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as column chromatography or high-performance liquid chromatography (HPLC) to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated liquid suitable for various applications.

In another aspect, the extracts of baby corn silk and baby corn husk may be obtained by aqueous extraction process comprising the steps of :
c) Aqueous Extraction Process:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Using distilled or purified water as the extraction solvent;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (c):
1. Baby Corn Silk: Combining the powdered baby corn silk with water in an extraction vessel in a solvent-to-material ratio in between 10:1 and 20:1 (v/v);
2. Baby Corn Husk: Mixing the powdered husk with water in a separate extraction vessel in a solvent-to-material ratio in between 10:1 and 20:1 (v/v);
vii. Extracting by combining each product obtained in step (iv) of step (c):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the hydro-ethanolic solvent and maintaining a solvent-to-material ratio of 10:1 to 20:1 (v/v);
2. Stirring continuously or agitating the mixture to enhance the extraction of bioactive compounds;
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a period of 1 to 4 hours depending on the efficiency of extraction;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as liquid- liquid extraction or column chromatography to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) of step (c) to obtain a stable powder or concentrated liquid suitable for various applications.

In another aspect, the extracts of baby corn silk and baby corn husk may be obtained by Supercritical Fluid Extraction (SFE) process comprising the steps of :
d) Supercritical Fluid Extraction (SFE) Process:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly with water to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Using supercritical carbon dioxide (CO2) as the extraction fluid as CO2 is preferred due to its ability to selectively dissolve a wide range of bioactive compounds under supercritical conditions;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (d):
1. Baby Corn Silk: Placing the powdered baby corn silk in the extraction chamber of the SFE apparatus and setting the extraction parameters, such as pressure and temperature as 73.8 bar for CO2 and around 31°C to achieve supercritical conditions;
2. Baby Corn Husk: Placing the powdered husk in a separate extraction chamber and setting the appropriate parameters for supercritical extraction;
vii. Combining the powdered baby corn silk and baby corn husk of step (iv) in a single extraction chamber, adjusting the SFE parameters such as temperature between 31°C and 60°C; pressure between 70 bar and 300 bar for 1 to 4 hours depending on the desired yield and efficiency, to achieve supercritical conditions suitable for extracting compounds from both materials;
viii. Concentrating the filtered extract using techniques such as evaporation or solvent removal for obtaining a more concentrated extract;
ix. Purifying the concentrated extract as obtained in step (xvii) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
x. Drying the purified extract as obtained in step (xviii) to obtain a stable powder or concentrated liquid suitable for various applications.

In another aspect, the extracts of baby corn silk and baby corn husk may be obtained by Ultrasonic-Assisted Extraction process comprising the steps of :
e) Ultrasonic-Assisted Extraction Process:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing an appropriate solvent for extraction, such as water, ethanol, or a hydro-ethanolic mixture, depending on the solubility of the desired bioactive compounds;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (e):
1. Baby Corn Silk: combining the powdered baby corn silk with the prepared solvent in a ratio of 1:4 in an extraction vessel;
2. Baby Corn Husk: mixing the powdered husk with the solvent in a ratio of 1:4 in a separate extraction vessel;
vii. Extracting by combining each product as obtained in step (iv) of step (e):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the chosen solvent;
2. Performing ultrasonic-assisted extraction by placing the extraction vessel in an ultrasonic bath or using an ultrasonic probe to apply ultrasonic waves to the mixture by using ultrasonic frequencies range from 20 kHz to 40 kHz for 15 to 60 minutes depending on the efficiency of extraction and the nature of the material, maintaining the extraction temperature at ambient or slightly elevated temperatures to optimize extraction without degrading bioactive compounds, and agitating the mixture during ultrasonic treatment to further enhance extraction efficiency;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract of step (viii) using a rotary evaporator or solvent removal for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated liquid suitable for various applications.

In another aspect, the extracts of baby corn silk and baby corn husk may be obtained by Microwave-Assisted Extraction (MAE) process comprising the steps of :
f) Microwave-Assisted Extraction (MAE) Process:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing an appropriate solvent for extraction, such as water, ethanol, or a hydro-ethanolic mixture, based on the solubility of the bioactive compounds;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (f):
1. Baby Corn Silk: placing the powdered baby corn silk in a microwave-assisted extraction vessel and adding the prepared solvent in a ratio of 1:4;
2. Baby Corn Husk: placing the powdered husk in a separate extraction vessel with the solvent in a ratio of 1:4;
vii. Mixing the powdered baby corn silk and husk of step (iv) in a single extraction vessel with the chosen solvent as obtained in step (v);
viii. Performing Microwave-Assisted Extraction by placing the extraction vessel in a microwave extractor, adjusting the microwave power between 300 to 800 watts depending on the extraction requirements for 5 to 30 minutes depending on the material and desired efficiency, and maintaining the extraction temperature at optimal levels, usually between 50°C and 100°C to prevent degradation of bioactive compounds;
ix. Stirring the mixture during microwave treatment to ensure even exposure to microwave energy and improve extraction efficiency;
x. Allowing the mixture to cool to room temperature after microwave treatment;
xi. Filtering the mixture of step (x) using filter paper or centrifuging to separate the liquid extract from the solid residues;
xii. Concentrating the filtered extract using a rotary evaporator or solvent removal for obtaining a more concentrated extract;
xiii. Purifying the concentrated extract as obtained in step (xii) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
xiv. Drying the purified extract as obtained in step (xiii) to obtain a stable powder or concentrated liquid suitable for various applications.

The present invention provides optimization of the extraction parameters for each technique to maximize the yield of bioactive compounds while ensuring the extracts' safety, stability, and efficacy for various applications.

In another aspect, the present invention provides a formulation of a potent herbal composition by combining baby corn silk and baby corn husk extract with specific herbs.

In another aspect, the present composition is useful for managing chronic conditions such as diabetes, obesity, and cancer.

DETAILED DESCRIPTION OF FIGURES:
Figure 1: Inhibition of Adipogenesis by synergistic weight loss support tablet/capsule formulated with Baby Corn Silk and Husk extract, combined with other specific herbal extracts (Example No. 2).
Figure 2: Dose- Response Curve: Breast Cancer Cells (MCF-7)
Figure 3: Dose- Response Curve: Prostate Cancer Cells (LNCaP)
Figure 4: Effect of Example No.1 Formulation and Metformin on Glucose Uptake in L6 Cells.

DETAILED DESCRIPTION OF THE INVENTION:
The invention will now be described in detail in connection with certain preferred and optional embodiments, so that various aspects thereof may be more fully understood and appreciated. However, any skilled person will appreciate the extent to which such embodiments could be extrapolated in practice.

Unless specified otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art, to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described.

Unless stated to the contrary, any of the words “contains”, “containing”, "including," "includes," "comprising," and "comprises" mean "including without limitation" and shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it. Embodiments of the invention are not mutually exclusive, but may be implemented in various combinations. The described embodiments of the invention and the disclosed examples are given for the purpose of illustration rather than limitation of the invention.

Further, words like “a”, “an”, “at least” and “the” should be construed to not only cover singular quantities but also plural quantities of the elements immediately following them.

The term "bioactive compounds" or "extracts" used herein interchangeably relates and means to the extracts of baby corn silk and baby corn husk of the present invention.

For the purpose of present invention the term ‘composition’ and ‘formulation’ are used interchangeably and mean the herbal composition comprising bioactive compounds extracted from baby corn silk and baby corn husk of the present invention.
The present invention focuses on processes that incorporates multiple extraction techniques to maximize the extraction efficiency and profile of bioactive compounds from baby corn silk and baby corn husk. This approach ensures that the extracts contain a wide range of active components with potential therapeutic benefits.

Accordingly, in a preferred embodiment, the present invention provides a novel herbal composition comprising extracts of baby corn silk in an amount in the range of 1.2 to 75 %, baby corn husk in an amount in the range of 1.2 to 75 %, either alone or in combination thereof.

In another embodiment, the present invention provides a novel herbal composition comprising extracts of baby corn silk in an amount of 30 %, baby corn husk in an amount of 14 %, either alone or in combination thereof.

In another embodiment, the composition of the present invention may comprise of acceptable excipients or additives selected from binders, diluents, surfactants, emulsifiers, carriers, lubricants, solvents, pH adjusters, colorants, essential oils, anti-caking agent, dispersing agent and the like, alone or mixtures thereof.

In another embodiment, the herbal composition of the present invention may comprise extracts of herbs selected from
i. Trigonella Foenum-Graecum (Fenugreek) extract in an amount in the range of 1.2 to 75 %, more preferably 18 %;
ii. Syzygium Cumini (Jamun) extract in an amount in the range of 0.5 to 30 %, more preferably 4.8 %;
iii. Berberis Aristata (Indian Barberry); extract in an amount in the range of 1.2 to 50 %, more preferably 18 %;
iv. Aegle Marmelos (Bael) extract in an amount in the range of 1.2 to 50 %, more preferably 24 %;
v. Ocimum Sanctum (Holy Basil or Tulsi) extract in an amount in the range of 1.5 to 45 %, more preferably 23.1 %;
vi. Cinnamomum Verum (True Cinnamon) extract in an amount in the range of 0.5 to 35 %, more preferably 4 %;
vii. Gymnema Sylvestre extract in an amount in the range of 0.5 to 35 %, more preferably 7 %;
viii. Momordica Charantia (Bitter Melon) extract in an amount in the range of 0.5 to 35 %, more preferably 10 %;
ix. Curcuma Longa (Turmeric) extract in an amount in the range of 0.5 to 35 %, more preferably 6 %;
x. Pterocarpus Marsupium extract in an amount in the range of 0.5 to 35 %, more preferably 8 %;
xi. Moringa Oleifera extract in an amount in the range of 0.5 to 35 %, more preferably 4.2 %;
xii. Tinospora Cardifolia (Guduchi or Giloy) extract in an amount in the range of 1.2 to 30 %, more preferably 6 %;
xiii. Neem Leaf (Azadirachta indica) extract in an amount in the range of 0.5 to 35 %, more preferably 16 %;
xiv. Andrographis Paniculata (Kalmegh) extract in an amount in the range of 1.5 to 40 %, more preferably 8 %; and
xv. Piper Longum (Long Pepper) extract in an amount in the range of 0.01 to 30 %, more preferably 1.2 %.

In an embodiment, the extracts of baby corn silk and baby corn husk of the present composition may be obtained by the processes selected from ethanolic extraction process, hydro-ethanolic extraction method, aqueous extraction process, supercritical fluid extraction (SFE) process, ultrasonic-assisted extraction process, and microwave-assisted extraction (MAE) process alone or combination thereof.

In another embodiment, the extracts were standardized based on their bioactive compound content such as flavonoids, polyphenols, and polysaccharides, to ensure consistency and efficacy.

Accordingly, in an embodiment, the extracts of baby corn silk and baby corn husk may be obtained by ethanolic extraction process comprising the steps of :
a) Ethanolic Extraction Process:
i. Collecting the fresh baby corn silk and baby corn husk from mature corn plants; ensuring the materials are clean and free from contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or impurities followed by drying the cleaned materials using air-drying or a low-temperature drying process to reduce moisture content while preserving bioactive compounds;
iii. Grinding the dried silk and husk into a coarse powder to enhance the surface area for extraction;
iv. Preparing a 70% to 90% concentrated ethanol solution based on the desired extraction efficiency;
v. Extracting individually by utilizing each product as obtained in step iii:
1. Baby Corn Silk: Combining the powdered baby corn silk with ethanol in an extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v); and
2. Baby Corn Husk: Mixing the powdered husk with ethanol in a separate extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
vi. Extracting by combining baby corn silk and baby corn husk in step (iii) by of step (a):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with ethanol and maintaining a solvent-to-material ratio of 5:1 to 10:1 (v/v);
2. Stirring continuously or agitating the mixture as obtained in step (1) of step (vi) to promote effective extraction of bioactive compounds; and
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a duration of 4 to 24 hours, depending on the efficiency required;
vii. Filtering the mixture as obtained in step (v) and (vi) using filter paper or a centrifuge to separate the liquid extract from the solid residues;
viii. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
ix. Purifying the concentrated extract as obtained in step (viii) using techniques such as column chromatography or high-performance liquid chromatography (HPLC) to isolate specific bioactive compounds; and
x. Drying the purified extract as obtained in step (ix) to obtain a stable powder or concentrated liquid suitable for various applications.

In another embodiment, the extracts of baby corn silk and baby corn husk may be obtained by hydro-ethanolic extraction method comprising the steps of:
b) Hydro-Ethanolic Extraction Method:
i. Obtaining fresh baby corn silk and baby corn husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing a hydro-ethanolic solvent by mixing water and a 30% to 70% concentrated ethanol solution based on the desired extraction efficiency;
vi. Extracting individually by utilizing each product as obtained in step iv:
1. Baby Corn Silk: Combining the powdered baby corn silk with the hydro-ethanolic solvent in an extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
2. Baby Corn Husk: Mixing the powdered husk with the hydro-ethanolic solvent in a separate extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
vii. Extracting by combining each product obtained in step (iv) of step (b):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the hydro-ethanolic solvent and maintaining a solvent-to-material ratio of 5:1 to 10:1 (v/v);
2. Stirring continuously or agitating the mixture to enhance the extraction of bioactive compounds;
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a period of 4 to 24 hours depending on the efficiency of extraction;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as column chromatography or high-performance liquid chromatography (HPLC) to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated liquid suitable for various applications.

In another embodiment, the extracts of baby corn silk and baby corn husk may be obtained by aqueous extraction process comprising the steps of :
c) Aqueous Extraction Process:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Using distilled or purified water as the extraction solvent;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (c):
1. Baby Corn Silk: Combining the powdered baby corn silk with water in an extraction vessel in a solvent-to-material ratio in between 10:1 and 20:1 (v/v);
2. Baby Corn Husk: Mixing the powdered husk with water in a separate extraction vessel in a solvent-to-material ratio in between 10:1 and 20:1 (v/v);
vii. Extracting by combining each product obtained in step (iv) of step (c):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the hydro-ethanolic solvent and maintaining a solvent-to-material ratio of 10:1 to 20:1 (v/v);
2. Stirring continuously or agitating the mixture to enhance the extraction of bioactive compounds;
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a period of 1 to 4 hours depending on the efficiency of extraction;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as liquid- liquid extraction or column chromatography to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) of step (c) to obtain a stable powder or concentrated liquid suitable for various applications.

In another embodiment, the extracts of baby corn silk and baby corn husk may be obtained by Supercritical Fluid Extraction (SFE) process comprising the steps of :
d) Supercritical Fluid Extraction (SFE) Process:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly with water to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Using supercritical carbon dioxide (CO2) as the extraction fluid as CO2 is preferred due to its ability to selectively dissolve a wide range of bioactive compounds under supercritical conditions;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (d):
1. Baby Corn Silk: Placing the powdered baby corn silk in the extraction chamber of the SFE apparatus and setting the extraction parameters, such as pressure and temperature as 73.8 bar for CO2 and around 31°C to achieve supercritical conditions;
2. Baby Corn Husk: Placing the powdered husk in a separate extraction chamber and setting the appropriate parameters for supercritical extraction;
vii. Combining the powdered baby corn silk and baby corn husk of step (iv) in a single extraction chamber, adjusting the SFE parameters such as temperature between 31°C and 60°C; pressure between 70 bar and 300 bar for 1 to 4 hours depending on the desired yield and efficiency, to achieve supercritical conditions suitable for extracting compounds from both materials;
viii. Concentrating the filtered extract using techniques such as evaporation or solvent removal for obtaining a more concentrated extract;
ix. Purifying the concentrated extract as obtained in step (xvii) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
x. Drying the purified extract as obtained in step (xviii) to obtain a stable powder or concentrated liquid suitable for various applications.

In another embodiment, the extracts of baby corn silk and baby corn husk may be obtained by Ultrasonic-Assisted Extraction process comprising the steps of :
e) Ultrasonic-Assisted Extraction Process:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing an appropriate solvent for extraction, such as water, ethanol, or a hydro-ethanolic mixture, depending on the solubility of the desired bioactive compounds;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (e):
1. Baby Corn Silk: combining the powdered baby corn silk with the prepared solvent in a ratio of 1:4 in an extraction vessel;
2. Baby Corn Husk: mixing the powdered husk with the solvent in a ratio of 1:4 in a separate extraction vessel;
vii. Extracting by combining each product as obtained in step (iv) of step (e):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the chosen solvent;
2. Performing ultrasonic-assisted extraction by placing the extraction vessel in an ultrasonic bath or using an ultrasonic probe to apply ultrasonic waves to the mixture by using ultrasonic frequencies range from 20 kHz to 40 kHz for 15 to 60 minutes depending on the efficiency of extraction and the nature of the material, maintaining the extraction temperature at ambient or slightly elevated temperatures to optimize extraction without degrading bioactive compounds, and agitating the mixture during ultrasonic treatment to further enhance extraction efficiency;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract of step (viii) using a rotary evaporator or solvent removal for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated liquid suitable for various applications.

In another aspect, the extracts of baby corn silk and baby corn husk may be obtained by Microwave-Assisted Extraction (MAE) process comprising the steps of :
f) Microwave-Assisted Extraction (MAE) Process:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing an appropriate solvent for extraction, such as water, ethanol, or a hydro-ethanolic mixture, based on the solubility of the bioactive compounds;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (f):
1. Baby Corn Silk: placing the powdered baby corn silk in a microwave-assisted extraction vessel and adding the prepared solvent in a ratio of 1:4;
2. Baby Corn Husk: placing the powdered husk in a separate extraction vessel with the solvent in a ratio of 1:4;
vii. Mixing the powdered baby corn silk and husk of step (iv) in a single extraction vessel with the chosen solvent as obtained in step (v);
viii. Performing Microwave-Assisted Extraction by placing the extraction vessel in a microwave extractor, adjusting the microwave power between 300 to 800 watts depending on the extraction requirements for 5 to 30 minutes depending on the material and desired efficiency, and maintaining the extraction temperature at optimal levels, usually between 50°C and 100°C to prevent degradation of bioactive compounds;
ix. Stirring the mixture during microwave treatment to ensure even exposure to microwave energy and improve extraction efficiency;
x. Allowing the mixture to cool to room temperature after microwave treatment;
xi. Filtering the mixture of step (x) using filter paper or centrifuging to separate the liquid extract from the solid residues;
xii. Concentrating the filtered extract using a rotary evaporator or solvent removal for obtaining a more concentrated extract;
xiii. Purifying the concentrated extract as obtained in step (xii) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
xiv. Drying the purified extract as obtained in step (xiii) to obtain a stable powder or concentrated liquid suitable for various applications.

The novelty of the present invention lies in optimizing the extraction of bioactive compounds from baby corn silk and also in its unique formulation. By combining baby corn silk extract with other herbs, such as Trigonella Foenum-Graecum (Fenugreek), Syzygium Cumini (Jamun), Berberis Aristata (Daruharidra), Aegle Marmelos (Bael), Ocimum Sanctum (Tulsi), Cinnamomum Verum (Cinnamon), Gymnema Sylvestre, Momordica Charantia (Bitter Melon), Curcuma Longa (Turmeric) and Pterocarpus Marsupium (Vijaysar), the therapeutic effects of the extract can be significantly enhanced.

In an embodiment, the present invention provides a process that incorporates multiple extraction techniques to maximize the extraction efficiency and profile of bioactive compounds from baby corn silk and baby corn husk. This approach ensures that the extracts contain a wide range of active components with potential therapeutic benefits.

In another embodiment, the present invention provides extracts with enhanced bioactivity due to the optimization of extraction conditions and techniques. This leads to more potent formulations with improved efficacy in various applications, such as anti-diabetic, anti-cancer, anti-obesity, anti-inflammatory, and immunomodulatory effects.

In another embodiment, the present invention provides sustainable and efficient extraction by integrating advanced extraction techniques. The process not only improves the yield and quality of bioactive compounds but also aligns with sustainable practices. Techniques such as SFE and UAE contribute to reduce the environmental impact and improving the overall efficiency of the extraction process.

In another embodiment, the present invention provides use of the extracted bioactive compounds from baby corn silk and husk, for a wide range of applications in the pharmaceutical, nutraceutical, and cosmetic industries.

In another embodiment, the present invention provides synergistic effect of the combination of herbs with baby corn silk extract and baby corn husk extract for targeting multiple pathways in the management of diabetes, obesity, and cancer.

In another embodiment, the present invention provides enhanced bioavailability by the use of certain herbs like fenugreek and cinnamon which may improve the absorption and bioavailability of the active compounds in baby corn silk.

In another embodiment, the composition of the present invention is non-toxic, safe and thus suitable for long-term use.

In another embodiment, the composition of the present invention not only targets specific diseases like diabetes and obesity but also provides general health benefits such as immune system support and anti-inflammatory effects.

In another embodiment, the optimization of the extraction parameters such as temperature, solvent concentration, extraction time, and solvent-to-material ratio for each said method is done to ensure maximum yield and bioactivity of the said extracts.

In another embodiment, the extracts were standardized based on their bioactive compound content such as flavonoids, polyphenols, and polysaccharides, to ensure consistency and efficacy.

In another embodiment, the combination of extracts of baby corn silk and baby corn husk alone or combination thereof with other herbal extracts such as Trigonella foenum-graecum, Syzygium cumini (Jamun), Berberis aristata, Aegle marmelos, Ocimum sanctum, Cinnamomum verum, Gymnema sylvestre, Momordica charantia, Curcuma longa, Pterocarpus marsupium, Moringa Oleifera, Tinospora Cardifolia, Azadirachta indica, Andrographis Paniculata and Piper Longum is useful in controlling medical disorders.

In an embodiment, the combination of baby corn silk or baby corn Husk extracts alone or combination thereof with these specific herbal extracts provides a synergistic formulation that helps in management of diabetes, inflammation, cancer, obesity, and other related disorders.

The present invention provides an innovative process utilizing advanced extraction techniques such as ethanolic extraction, hydro-ethanolic extraction, aqueous extraction, supercritical fluid extraction (SFE), ultrasonic-assisted extraction (UAE), and microwave-assisted extraction (MAE) to maximize the yield and bioactivity of the compounds. Additionally, the invention includes the formulation useful for the management and prevention of metabolic and chronic diseases such as diabetes, obesity, and cancer.

In an embodiment, the present invention provides optimized value of the safety and efficacy of a formulation combining baby corn silk extract with herbal extracts such as Trigonella foenum-graecum, Syzygium cumini (Jamun), Berberis aristata, Aegle marmelos, Ocimum sanctum, Cinnamomum verum, Gymnema sylvestre, Momordica charantia, Curcuma longa, Pterocarpus marsupium, Moringa Oleifera, Tinospora Cardifolia, Azadirachta indica, Andrographis Paniculata and Piper Longum.

The extraction techniques used in preparing the present extracts ensure that harmful contaminants are removed, and the concentration of active compounds is controlled, reducing the risk of toxicity or adverse reactions.

In an embodiment, the Hydro-ethanolic extract of Baby Corn Silk (individual), Aqueous extract of Baby Corn Silk and Husk (combined), and Supercritical extract of Baby Corn Silk and Husk (combined) exhibits enhanced long-term stability for more than 3 years, with negligible loss of bioactive compounds and no microbial or physicochemical deterioration.
In another embodiment, the composition of the present invention may be formulated as tablets, capsules, powders, granules, liquids, rings, solids, tablets, pastes, soft, jelly and rod types.

In another embodiment, the present invention provides a formulation comprising the herbal composition along with acceptable excipients.

In another embodiment, the present invention provides the use of the herbal composition for the management and prevention of metabolic and chronic diseases such as diabetes, inflammation, cancer, obesity, and other related disorders.

In another embodiment, the present invention provides a method for managing and preventing diabetes, inflammation, cancer, obesity, and other related disorders, comprising administering a therapeutically effective amount of the composition to a subject in need thereof.

In another embodiment, the present invention provides enhanced bioavailability of baby corn silk or baby corn Husk extract alone or combination thereof, when combined with herbal extracts such as Trigonella foenumgraecum, Syzygium cumini (Jamun), Berberis aristata, Aegle marmelos, Ocimum sanctum, Cinnamomum verum, Gymnema sylvestre, Momordica charantia, Curcuma longa, Pterocarpus marsupium, Moringa oleifera, Tinospora Cardifolia, Azadirachta indica, Andrographis Paniculata and Piper Longum.

In an embodiment, the present invention provides that the combination of baby corn silk extract with other potent herbal extracts enhance the bioavailability of the entire formulation, ensuring the active compounds are absorbed efficiently and remain stable in the body. This leads to more effective management of medical disorders such as diabetes, inflammation, cancer, and obesity providing a superior therapeutic option for patients.

In an embodiment, the present invention discloses a method for enhancing the bioavailability based on the following parameters:

1. Improved Absorption:
i) Curcuma longa (Turmeric) is known for its poor bioavailability, but when combined with other extracts like Ocimum sanctum and Cinnamomum verum, enhance the absorption, the overall bioavailability of curcumin and other bioactive compounds. ii) Baby corn silk extract, rich in flavonoids and other bioactive compounds enhancing interactions leading to improved systemic absorption.

2. Synergistic Enhancement:
i) The combination of Gymnema sylvestre and Momordica charantia with baby corn silk extract not only enhances their individual effects but also increases the bioavailability of key phytochemicals ensuring that the therapeutic benefits are more pronounced and longer-lasting.
ii) Syzygium cumini (Jamun), known for its antioxidant properties, works synergistically with these extracts to protect bioactive compounds from degradation, further enhancing their bioavailability.

3. Stabilization of Phytochemicals:
i) Berberis aristata and Aegle marmelos are known to stabilize the active compounds within a formulation when combining with baby corn silk extract, this stabilization further prevents the breakdown of bioactive compounds ensuring they remain potent until they are absorbed and maintaining the efficacy of the formulation over time.

4. Health Benefits:
i) The enhanced bioavailability of this synergistic combination means that the formulation can more effectively target medical disorders such as diabetes, inflammation, cancer, and obesity.
ii) The higher bioavailability ensures that lower doses can be used while achieving maximum therapeutic effects, reducing the potential for side effects.

Accordingly, the individual components of the formulation have been studied extensively, with many clinical trials supporting their efficacy in treating diabetes, inflammation, and metabolic disorders. Combining these extracts can enhance their therapeutic effects through synergistic interactions, making the formulation more effective than the individual components used separately. The formulation of baby corn silk extract combined with herbal extracts is both safe and effective for managing conditions such as diabetes, inflammation, cancer, and obesity.

The present invention has multiple advantages/benefits such as –

1. Enhanced Therapeutic Efficacy:
i) Synergistic Actions: Combining baby corn silk and husk (individually or in combination) extract with other herbs produces synergistic effects such as baby corn silk utilized for its diuretic and anti-inflammatory properties whereas other herbs complement these said effects with additional benefits such as improved blood sugar regulation or enhanced immune support.

2. Health Benefits:
i) Anti-Diabetic: Combining Trigonella Foenum (Fenugreek) and Gymnema Sylvestre with baby corn silk or husk (individually or in combination) enhances the management of diabetes through improved glycemic control.
ii) Anti-Cancer: The combination of Curcuma Longa (Turmeric) with baby corn silk or husk (individually or in combination) and Pterocarpus Marsupium support cancer treatment.
iii) Anti-Obesity: Combining Momordica Charantia (Bitter Melon) and Cinnamomum Verum (Cinnamon) with baby corn silk or husk (individually or in combination) provides improved effectiveness in anti-obesity.
iv) Anti-Inflammatory: The combination of Ocimum Sanctum (Tulsi) and Berberis Aristata with baby corn silk or husk (individually or in combination) provides a potent anti-inflammatory formulation.
v) Immunomodulatory: The combination of Moringa Oleifera, Tinospora Cardifolia (Guduchi), Neem Leaf, Long Pepper (Piper Longum) and Kalmegh (Andrographis Paniculata) with baby corn silk and husk (individually or in combination) improves immune health.
vi) Other related disorders: The formulation are also beneficial in managing related metabolic disorders, such as hyperlipidemia, by improving lipid profiles and reducing oxidative stress.

3. Improved Bioavailability and Efficacy:
i) Complementary Mechanisms: Different herbs enhance the bioavailability and efficacy of each other’s bioactive compounds such as the presence of one herb might improve the absorption of another’s active ingredients, leading to better therapeutic outcomes.
ii) Extended Activity: Combining herbs extend the duration of bioactive compound activity, further offering sustained health benefits.

The present composition targets blood sugar levels, reduce inflammation, support immune function, and assist with weight management.

EXAMPLES
The following examples, which include preferred embodiments, will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for purpose of illustrative discussion of preferred embodiments of the invention.

Example:
a) Ethanolic Extraction Process to obtain extracts of baby corn silk and baby corn husk comprising the steps of:
i. Collecting the fresh baby corn silk and baby corn husk from mature corn plants; ensuring the materials are clean and free from contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or impurities followed by drying the cleaned materials using air-drying or a low-temperature drying process to reduce moisture content while preserving bioactive compounds;
iii. Grinding the dried silk and husk into a coarse powder to enhance the surface area for extraction;
iv. Preparing a 70% to 90% concentrated ethanol solution based on the desired extraction efficiency;
v. Extracting individually by utilizing each product as obtained in step iii:
1. Baby Corn Silk: Combining the powdered baby corn silk with ethanol in an extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v); and
2. Baby Corn Husk: Mixing the powdered husk with ethanol in a separate extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
vi. Extracting by combining baby corn silk and baby corn husk in step (iii) by of step (a):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with ethanol and maintaining a solvent-to-material ratio of 5:1 to 10:1 (v/v);
2. Stirring continuously or agitating the mixture as obtained in step (1) of step (vi) to promote effective extraction of bioactive compounds; and
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a duration of 4 to 24 hours, depending on the efficiency required;
vii. Filtering the mixture as obtained in step (v) and (vi) using filter paper or a centrifuge to separate the liquid extract from the solid residues;
viii. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
ix. Purifying the concentrated extract as obtained in step (viii) using techniques such as column chromatography or high-performance liquid chromatography (HPLC) to isolate specific bioactive compounds; and
x. Drying the purified extract as obtained in step (ix) to obtain a stable powder or concentrated liquid suitable for various applications.
b) Hydro-Ethanolic Extraction Method to obtain extracts of baby corn silk and baby corn husk comprising the steps of:
i. Obtaining fresh baby corn silk and baby corn husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing a hydro-ethanolic solvent by mixing water and a 30% to 70% concentrated ethanol solution based on the desired extraction efficiency;
vi. Extracting individually by utilizing each product as obtained in step iv:
1. Baby Corn Silk: Combining the powdered baby corn silk with the hydro-ethanolic solvent in an extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
2. Baby Corn Husk: Mixing the powdered husk with the hydro-ethanolic solvent in a separate extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
vii. Extracting by combining each product obtained in step (iv) of step (b):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the hydro-ethanolic solvent and maintaining a solvent-to-material ratio of 5:1 to 10:1 (v/v);
2. Stirring continuously or agitating the mixture to enhance the extraction of bioactive compounds;
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a period of 4 to 24 hours depending on the efficiency of extraction;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as column chromatography or high-performance liquid chromatography (HPLC) to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated liquid suitable for various applications.

c) Aqueous Extraction Process to obtain extracts of baby corn silk and baby corn husk comprising the steps of:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Using distilled or purified water as the extraction solvent;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (c):
1. Baby Corn Silk: Combining the powdered baby corn silk with water in an extraction vessel in a solvent-to-material ratio in between 10:1 and 20:1 (v/v);
2. Baby Corn Husk: Mixing the powdered husk with water in a separate extraction vessel in a solvent-to-material ratio in between 10:1 and 20:1 (v/v);
vii. Extracting by combining each product obtained in step (iv) of step (c):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the hydro-ethanolic solvent and maintaining a solvent-to-material ratio of 10:1 to 20:1 (v/v);
2. Stirring continuously or agitating the mixture to enhance the extraction of bioactive compounds;
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a period of 1 to 4 hours depending on the efficiency of extraction;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as liquid- liquid extraction or column chromatography to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) of step (c) to obtain a stable powder or concentrated liquid suitable for various applications.

d) Supercritical Fluid Extraction (SFE) Process to obtain extracts of baby corn silk and baby corn husk comprising the steps of:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly with water to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Using supercritical carbon dioxide (CO2) as the extraction fluid as CO2 is preferred due to its ability to selectively dissolve a wide range of bioactive compounds under supercritical conditions;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (d):
1. Baby Corn Silk: Placing the powdered baby corn silk in the extraction chamber of the SFE apparatus and setting the extraction parameters, such as pressure and temperature as 73.8 bar for CO2 and around 31°C to achieve supercritical conditions;
2. Baby Corn Husk: Placing the powdered husk in a separate extraction chamber and setting the appropriate parameters for supercritical extraction;
vii. Combining the powdered baby corn silk and baby corn husk of step (iv) in a single extraction chamber, adjusting the SFE parameters such as temperature between 31°C and 60°C; pressure between 70 bar and 300 bar for 1 to 4 hours depending on the desired yield and efficiency, to achieve supercritical conditions suitable for extracting compounds from both materials;
viii. Concentrating the filtered extract using techniques such as evaporation or solvent removal for obtaining a more concentrated extract;
ix. Purifying the concentrated extract as obtained in step (xvii) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
x. Drying the purified extract as obtained in step (xviii) to obtain a stable powder or concentrated liquid suitable for various applications.

e) Ultrasonic-Assisted Extraction Process to obtain extracts of baby corn silk and baby corn husk comprising the steps of:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing an appropriate solvent for extraction, such as water, ethanol, or a hydro-ethanolic mixture, depending on the solubility of the desired bioactive compounds;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (e):
1. Baby Corn Silk: combining the powdered baby corn silk with the prepared solvent in a ratio of 1:4 in an extraction vessel;
2. Baby Corn Husk: mixing the powdered husk with the solvent in a ratio of 1:4 in a separate extraction vessel;
vii. Extracting by combining each product as obtained in step (iv) of step (e):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the chosen solvent;
2. Performing ultrasonic-assisted extraction by placing the extraction vessel in an ultrasonic bath or using an ultrasonic probe to apply ultrasonic waves to the mixture by using ultrasonic frequencies range from 20 kHz to 40 kHz for 15 to 60 minutes depending on the efficiency of extraction and the nature of the material, maintaining the extraction temperature at ambient or slightly elevated temperatures to optimize extraction without degrading bioactive compounds, and agitating the mixture during ultrasonic treatment to further enhance extraction efficiency;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract of step (viii) using a rotary evaporator or solvent removal for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated liquid suitable for various applications.

f) Microwave-Assisted Extraction (MAE) Process to obtain extracts of baby corn silk and baby corn husk comprising the steps of:
i. Obtaining fresh baby corn silk and husk from mature corn plants, ensuring that the materials are clean and free of contaminants;
ii. Rinsing the silk and husk thoroughly to remove any dirt or foreign materials;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing an appropriate solvent for extraction, such as water, ethanol, or a hydro-ethanolic mixture, based on the solubility of the bioactive compounds;
vi. Extracting individually by utilizing each product as obtained in step (iv) of step (f):
1. Baby Corn Silk: placing the powdered baby corn silk in a microwave-assisted extraction vessel and adding the prepared solvent in a ratio of 1:4;
2. Baby Corn Husk: placing the powdered husk in a separate extraction vessel with the solvent in a ratio of 1:4;
vii. Mixing the powdered baby corn silk and husk of step (iv) in a single extraction vessel with the chosen solvent as obtained in step (v);
viii. Performing Microwave-Assisted Extraction by placing the extraction vessel in a microwave extractor, adjusting the microwave power between 300 to 800 watts depending on the extraction requirements for 5 to 30 minutes depending on the material and desired efficiency, and maintaining the extraction temperature at optimal levels, usually between 50°C and 100°C to prevent degradation of bioactive compounds;
ix. Stirring the mixture during microwave treatment to ensure even exposure to microwave energy and improve extraction efficiency;
x. Allowing the mixture to cool to room temperature after microwave treatment;
xi. Filtering the mixture of step (x) using filter paper or centrifuging to separate the liquid extract from the solid residues;
xii. Concentrating the filtered extract using a rotary evaporator or solvent removal for obtaining a more concentrated extract;
xiii. Purifying the concentrated extract as obtained in step (xii) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
xiv. Drying the purified extract as obtained in step (xiii) to obtain a stable powder or concentrated liquid suitable for various applications.

Example 1: Anti-Diabetic tablet/capsule:
Table 1
Ingredient Weight serves per 500 mg capsule/tablet Percent by weight Range ( percent by weight)
Hydro-ethanolic extract of Baby corn (Zea mays) silk 120 mg 24 % 1.2-75 %
Aqueous extract of Baby corn (Zea mays) silk and husk (combine) 80 mg 16 % 1.2-75 %
Supercritical extract of Baby corn (Zea mays) silk and husk (combine) 30 mg 6 % 0.5- 35 %
Aqueous extract of Fenugreek (Trigonella Foenum) seeds 88 mg 17.6 % 1.2-75 %
Hydro-ethanolic extract of Vijayasar (Pterocarpus marsupium) Heartwood 40 mg 8 % 0.5- 35 %
Hydro-ethanolic extract of Gymnema sylvestre leaves 35 gm 7 % 0.5- 35 %
Hydro-ethanolic extract of Turmeric (Curcuma Longa) rhizome. 25 mg 5 % 0.5- 35 %
Aqueous extract of jamun (syzgium cumini) bark 24 mg 4.8 % 0.5- 30 %
Supercritical extract of cinnamon (Cinnamomum verum) bark 26 mg 5.2 % 0.5- 35 %
Supercritical extract of Guduchi (Tinospora cardifolia) bark 23 mg 4.6 % 0.5- 35 %
Supercritical extract of Long pepper (Piper Longum) bark 5 mg 1 % 0.01- 30 %
CAB-O-SIL 4 mg 0.8 % 0.001- 5 %

Procedure: All the ingredients were blended in blender or rapid mixture granulator for 45 minutes to thoroughly mix the herbal extracts with excipients and to ensure uniform distribution of all components screen.

Wet Granulation: A binder solution (e.g., starch paste) was prepared and added to the blended powder to form a wet mass. The wet mass was passed through a sieve to form granules of uniform size. The granules were dried in a tray dryer or fluid bed dryer to remove moisture. The dried granules were screened to obtain a uniform particle size distribution.

Dry Granulation: The blended powder was compressed into large tablets (slugs) or compacts using a roller compactor. The slugs or compacts were milled to produce granules of the desired size.

Tablet Compression: The granules were compressed into tablets using a tablet press. The machine settings were adjusted to control the tablet weight, thickness, and hardness. The tablet properties such as weight variation, hardness, and disintegration time were monitored during compression to ensure consistency. If needed a coating was applied to the tablets to mask taste, improve stability, or control the release of active ingredients. Coating was done using a pan coater or fluidized bed coater.

Capsule Filling: An appropriate capsule size was chosen based on the bulk density and weight of the blended powder. The powder or granules was filled into empty gelatin or HPMC capsules using an automatic or semi-automatic capsule-filling machine. For additional protection, the capsules were sealed to prevent tampering or leakage.

Under normal conditions, a 500 mg dose would typically be administered multiple times daily. The exact dosage may vary based on factors such as body weight and other relevant conditions and other comorbidities, which can be determined by those skilled in the field after reviewing the application. The administration is usually oral, delivered through a tablet or capsule.

Example 2: Weight loss tablet/capsule:

Table 2
Ingredient Weight serves per 500 mg capsule/tablet Percent by weight Range ( percent by weight)
Hydro-ethanolic extract of Baby corn (Zea mays) silk 150 mg 30 % 1.2-75 %
Aqueous extract of Baby corn (Zea mays) silk and husk (combine) 70 mg 14 % 1.2-75 %
Supercritical extract of Baby corn (Zea mays) silk and husk (combine) 30 mg 6 % 0.5- 35 %
Aqueous extract of Fenugreek (Trigonella Foenum) seeds 90 mg 18 % 1.2-75 %
Hydro-ethanolic extract of bitter melon (Momordica charanti) fruit 70 mg 14 % 0.5- 35 %
Hydro-ethanolic extract of moringa oleifera leaves 21 gm 4.2 % 0.5- 35 %
Hydro-ethanolic extract of Turmeric (Curcuma Longa) rhizome. 10 mg 2 % 0.5- 35 %
Supercritical extract of cinnamon (Cinnamomum verum) bark 10 mg 2 % 0.5- 35 %
Hydro-ethanolic extract of Indian Barberry (Berberis aristata) rhizome. 10 mg 2 % 0.5- 35 %
Supercritical extract of Long pepper (Piper Longum) bark 5 mg 1 % 0.01- 30 %
Acetyl L-carnitine 10 mg 2 % 0.5- 35 %
Niacinamide 10 mg 2 % 0.5- 35 %
Vitamin B-6 (Pyridoxine HCL) 10 mg 2 % 0.5- 35 %
CAB-O-SIL 4 mg 0.8 % 0.001- 5 %

Procedure: All the ingredients were blended in blender or rapid mixture granulator for 45 minutes to thoroughly mix the herbal extracts with excipients and to ensure uniform distribution of all components screen.

Wet Granulation: A binder solution (e.g., starch paste) was prepared and added to the blended powder to form a wet mass. The wet mass was passed through a sieve to form granules of uniform size. The granules were dried in a tray dryer or fluid bed dryer to remove moisture. The dried granules were screened to obtain a uniform particle size distribution.

Dry Granulation: The blended powder was compressed into large tablets (slugs) or compacts using a roller compactor. The slugs or compacts were milled to produce granules of the desired size.

Tablet Compression: he granules were compressed into tablets using a tablet press. The machine settings were adjusted to control the tablet weight, thickness, and hardness. The tablet properties such as weight variation, hardness, and disintegration time were monitored during compression to ensure consistency. If needed a coating was applied to the tablets to mask taste, improve stability, or control the release of active ingredients. Coating was done using a pan coater or fluidized bed coater.

Capsule Filling: An appropriate capsule size was chosen based on the bulk density and weight of the blended powder. The powder or granules was filled into empty gelatin or HPMC capsules using an automatic or semi-automatic capsule-filling machine. For additional protection, the capsules were sealed to prevent tampering or leakage.
Under normal conditions, a 500 mg dose would typically be administered multiple times daily. The exact dosage may vary based on factors such as body weight and other relevant conditions and other comorbidities, which can be determined by those skilled in the field after reviewing the application. The administration is usually oral, delivered through a tablet or capsule.

Example 3: Anti-cancer tablet/capsule:

Table 3
Ingredient Weight serves per 500 mg capsule/tablet Percent by weight Range ( percent by weight)
Hydro-ethanolic extract of Baby corn (Zea mays) silk 91 mg 18.2 % 1.2-75 %
Aqueous extract of Baby corn (Zea mays) silk and husk (combine) 90 mg 18 % 1.2-75 %
Supercritical extract of Baby corn (Zea mays) silk and husk (combine) 40 mg 8 % 0.5- 35 %
Hydro-ethanolic extract of Bael (Aegle Marmelos) fruit 20 mg 4 % 1.2-75 %
Hydro-ethanolic extract of Vijayasar (Pterocarpus marsupium) Heartwood 35 mg 7 % 0.5- 35 %
Hydro-ethanolic extract of Neem (Azadirachta indica) leaves 60 mg 12 % 1.2-75 %
Hydro-ethanolic extract of Kalmegh (Andrographis paniculata) leaves 30 mg 6 % 0.5- 35 %
Supercritical extract of Neem (Azadirachta indica) leaves 20 gm 4 % 0.5- 35 %
Hydro-ethanolic extract of Turmeric (Curcuma Longa) rhizome. 25 mg 5 % 0.5- 35 %
Hydro-ethanolic extract of Basil (Ocimum sanctum) leaves 30 mg 6 % 0.5- 35 %
Aqueous extract of jamun (syzgium cumini) bark 10mg 2 % 0.5- 30 %
Supercritical extract of cinnamon (Cinnamomum verum) bark 20 mg 4 % 0.5- 35 %
Supercritical extract of Guduchi (Tinospora cardifolia) bark 20 mg 4 % 0.5- 35 %
Supercritical extract of Long pepper (Piper Longum) bark 5 mg 1 % 0.01- 30 %
CAB-O-SIL 4 mg 0.8 % 0.001- 5 %

Procedure: All the ingredients were blended in blender or rapid mixture granulator for 45 minutes to thoroughly mix the herbal extracts with excipients and to ensure uniform distribution of all components screen.

Wet Granulation: A binder solution (e.g., starch paste) was prepared and added to the blended powder to form a wet mass. The wet mass was passed through a sieve to form granules of uniform size. The granules were dried in a tray dryer or fluid bed dryer to remove moisture. The dried granules were screened to obtain a uniform particle size distribution.

Dry Granulation: The blended powder was compressed into large tablets (slugs) or compacts using a roller compactor. The slugs or compacts were milled to produce granules of the desired size.
Tablet Compression: The granules were compressed into tablets using a tablet press. The machine settings were adjusted to control the tablet weight, thickness, and hardness. The tablet properties such as weight variation, hardness, and disintegration time were monitored during compression to ensure consistency. If needed a coating was applied to the tablets to mask taste, improve stability, or control the release of active ingredients. Coating was done using a pan coater or fluidized bed coater.

Capsule Filling: An appropriate capsule size was chosen based on the bulk density and weight of the blended powder. The powder or granules were filled into empty gelatin or HPMC capsules using an automatic or semi-automatic capsule-filling machine. For additional protection, the capsules may be sealed to prevent tampering or leakage.

Under normal conditions, a 500 mg dose would typically be administered multiple times daily. The exact dosage may vary based on factors such as body weight and other relevant conditions and other comorbidities, which can be determined by those skilled in the field after reviewing the application. The administration is usually oral, delivered through a tablet or capsule.

Example 4: Multi-Vitamin & Mineral supplement tablet/capsule:

Table 4
Ingredient Weight serves per 500 mg capsule/tablet Percent by weight Range ( percent by weight)
Hydro-ethanolic extract of Baby corn (Zea mays) silk 120 mg 24 % 1.2-75 %
Aqueous extract of Baby corn (Zea mays) silk and husk (combine) 100 mg 20 % 1.2-75 %
Supercritical extract of Baby corn (Zea mays) silk and husk (combine) 37 mg 7.4 % 0.5- 35 %
Vitamin B-1 (Thiamin Nitrate)
10 mg 2 % 0.01- 30 %
Vitamin B-2 (Riboflavin) 10 mg 2 % 0.01- 30 %
Inositol Hexanicotinate, Niacinamide & Niacin 20 mg 4 % 0.5-35 %
Vitamin B-5 (Calcium D-Pantothenate) 10 mg 2 % 0.01- 30 %
Vitamin B-6 ((Phyridoxine HCL 10 gm 2 % 0.01- 30 %
Vitamin C (Magnesium, Manganese & Zinc Ascorbates) 110 mg 22 % 1.5- 40 %
Boron (Amino Acid Chelate) 2 mg 0.4 % 0.5- 35 %
Calcium (Succinate, Carbonate, Malate) 20 mg 4 % 0.5- 30 %
Copper (Sebacate)
1 mg 0.2 % 0.01- 30 %
Manganese (Ascorbate) 30 mg 6 % 0.5- 35 %
Potassium (Succinate, alpha Ketoglutarate) 10 mg 2 % 0.01- 30 %
Zinc (Zinc Monomethionine & Ascorbate 10 mg 2 % 0.01- 30 %

Procedure: All the ingredients were blended in blender or rapid mixture granulator for 45 minutes to thoroughly mix the herbal extracts with excipients and to ensure uniform distribution of all components screen.

Wet Granulation: A binder solution (e.g., starch paste) was prepared and added to the blended powder to form a wet mass. The wet mass was passed through a sieve to form granules of uniform size. The granules were dried in a tray dryer or fluid bed dryer to remove moisture. The dried granules were screened to obtain a uniform particle size distribution.

Dry Granulation: The blended powder was compressed into large tablets (slugs) or compacts using a roller compactor. The slugs or compacts were milled to produce granules of the desired size.

Tablet Compression: The granules were compressed into tablets using a tablet press. The machine settings were adjusted to control the tablet weight, thickness, and hardness. The tablet properties such as weight variation, hardness, and disintegration time were monitored during compression to ensure consistency. If needed a coating was applied to the tablets to mask taste, improve stability, or control the release of active ingredients. Coating was done using a pan coater or fluidized bed coater.

Capsule Filling: An appropriate capsule size was chosen based on the bulk density and weight of the blended powder. The powder or granules were filled into empty gelatin or HPMC capsules using an automatic or semi-automatic capsule-filling machine. For additional protection, the capsules were sealed to prevent tampering or leakage.

Under normal conditions, a 500 mg dose would typically be administered multiple times daily. The exact dosage may vary based on factors such as body weight and other relevant conditions and other comorbidities, which can be determined by those skilled in the field after reviewing the application. The administration is usually oral, delivered through a tablet or capsule.

Example 5: Kidney support tablet/capsule:
Table 5
Ingredient Weight serves per 500 mg capsule/tablet Percent by weight Range ( percent by weight)
Hydro-ethanolic extract of Baby corn (Zea mays) silk 150 mg 30 % 1.2-75 %
Aqueous extract of Baby corn (Zea mays) silk and husk (combine) 95.5 mg 19.1 % 1.2-45 %
Supercritical extract of Baby corn (Zea mays) silk and husk (combine) 20 mg 4 % 0.5- 25 %
Supercritical extract of Guduchi (Tinospora cordifolia) stem 30 mg 6 % 1.2-30 %
Hydro-ethanolic extract of Basil (Ocimum sanctum) Aerial part 115.5 mg 23.1 % 1.5- 45 %
Hydro-ethanolic extract of Neem (Azadirachta indica) leaves 80 mg 16 % 0.5- 35 %
Supercritical extract of Long pepper (Piper Longum) fruit 5 mg 1 % 0.01- 30 %
CAB-O-SIL 4 mg 0.8 % 0.001- 5 %

Procedure: All the ingredients were blended in blender or rapid mixture granulator for 45 minutes to thoroughly mix the herbal extracts with excipients and to ensure uniform distribution of all components screen.
Wet Granulation: A binder solution (e.g., starch paste) was prepared and added to the blended powder to form a wet mass. The wet mass was passed through a sieve to form granules of uniform size. The granules were dried in a tray dryer or fluid bed dryer to remove moisture. The dried were screened granules to obtain a uniform particle size distribution.
Dry Granulation: The blended powder was compressed into large tablets (slugs) or compacts using a roller compactor. The slugs or compacts were milled to produce granules of the desired size.
Tablet Compression: The granules were compressed into tablets using a tablet press. The machine settings were adjusted to control the tablet weight, thickness, and hardness. The tablet properties such as weight variation, hardness, and disintegration time were monitored during compression to ensure consistency. If needed a coating was applied to the tablets to mask taste, improve stability, or control the release of active ingredients. Coating was done using a pan coater or fluidized bed coater.
Capsule Filling: An appropriate capsule size was chosen based on the bulk density and weight of the blended powder. The powder or granules were filled into empty gelatin or HPMC capsules using an automatic or semi-automatic capsule-filling machine. For additional protection, the capsules were sealed to prevent tampering or leakage.
Under normal conditions, a 500 mg dose would typically be administered multiple times daily. The exact dosage may vary based on factors such as body weight and other relevant conditions other comorbidities, which can be determined by those skilled in the field after reviewing the application. The administration is usually oral, delivered through a tablet or capsule.
Example 6: Digestive support tablet/capsule:
Table 6
Ingredient Weight serves per 500 mg capsule/tablet Percent by weight Range ( percent by weight)
Hydro-ethanolic extract of Baby corn (Zea mays) silk 130 mg 26 % 1.2-55 %
Aqueous extract of Baby corn (Zea mays) silk and husk (combine) 50 mg 10 % 1.2-45 %
Supercritical extract of Baby corn (Zea mays) silk and husk (combine) 30 mg 6 % 0.5- 25 %
Hydro-ethanolic extract of Bael (Aegle Marmelos) dried fruit 120 mg 24 % 1.2-50 %
Hydro-ethanolic extract of Fenugreek (Trigonella Foenum-Graecum) dried seed 80 mg 16 % 1.5- 45 %
Hydro-ethanolic extract of Bitter melon (Momordica Charantia) fruit 50 mg 10 % 0.5- 35 %
Hydro-ethanolic extract of Turmeric (Curcuma Longa) dried rhizome 30 mg 6 % 0.5- 35 %
Supercritical extract of long pepper (Piper Longum) fruit 6 mg 1.2 % 0.01- 30 %
CAB-O-SIL 4 mg 0.8 % 0.001- 5 %

Procedure: All the ingredients were blended in blender or rapid mixture granulator for 45 minutes thoroughly mix the herbal extracts with excipients and to ensure uniform distribution of all components screen.
Wet Granulation: A binder solution (e.g., starch paste) was prepared and added to the blended powder to form a wet mass. The wet mass was passed through a sieve to form granules of uniform size. The granules were dried in a tray dryer or fluid bed dryer to remove moisture. The dried granules were screened to obtain a uniform particle size distribution.
Dry Granulation: The blended powder was compressed into large tablets (slugs) or compacts using a roller compactor. The slugs or compacts were milled to produce granules of the desired size.
Tablet Compression: The granules were compressed into tablets using a tablet press. The machine settings were adjusted to control the tablet weight, thickness, and hardness. The tablet properties such as weight variation, hardness, and disintegration time were monitored during compression to ensure consistency. If needed, a coating was applied to the tablets to mask taste, improve stability, or control the release of active ingredients. Coating was done using a pan coater or fluidized bed coater.
Capsule Filling: An appropriate capsule size was chosen based on the bulk density and weight of the blended powder. The powder or granules were filled into empty gelatin or HPMC capsules using an automatic or semi-automatic capsule-filling machine. For additional protection, the capsules were sealed to prevent tampering or leakage.
Under normal conditions, a 500 mg dose would typically be administered multiple times daily. The exact dosage may vary based on factors such as body weight and other relevant conditions other comorbidities, which can be determined by those skilled in the field after reviewing the application. The administration is usually oral, delivered through a tablet or capsule.
Example 7: Anti Inflammatory support tablet/capsule:
Table 7
Ingredient Weight serves per 500 mg capsule/tablet Percent by weight Range ( percent by weight)
Hydro-ethanolic extract of Baby corn (Zea mays) silk 90 mg 18 % 1.2-50 %
Aqueous extract of Baby corn (Zea mays) silk and husk (combine) 70 mg 14 % 1.2-45 %
Supercritical extract of Baby corn (Zea mays) silk and husk (combine) 30 mg 6 % 0.5- 20 %
Hydro-ethanolic extract of Indian Barberry (Berberis Aristata) dried root 90 mg 18 % 1.2-50 %
Hydro-ethanolic extract of Kalmegh (Andrographis Paniculata) dried aerial part 40 mg 8 % 1.5- 40 %
Hydro-ethanolic extract of Moringa (Moringa Oleifera) fruit 90 mg 18 % 0.5- 45 %
Hydro-ethanolic extract of Turmeric (Curcuma Longa) dried rhizome 30 mg 6 % 0.5- 30 %
Hydro-ethanolic extract of Basil (Ocimum Sanctum) dried rhizome 50 mg 10 % 0.5- 35 %
Supercritical extract of long pepper (Piper Longum) fruit 6 mg 1.2 % 0.01- 30 %
CAB-O-SIL 4 mg 0.8 % 0.001- 5 %

Procedure: All the ingredients were blended in blender or rapid mixture granulator for 45 minutes to thoroughly mix the herbal extracts with excipients and to ensure uniform distribution of all components screen.
Wet Granulation: A binder solution (e.g., starch paste) was prepared and added to the blended powder to form a wet mass. The wet mass was passed through a sieve to form granules of uniform size. The granules were dried in a tray dryer or fluid bed dryer to remove moisture. The dried granules were screened to obtain a uniform particle size distribution.
Dry Granulation: The blended powder was compressed into large tablets (slugs) or compacts using a roller compactor. The slugs or compacts were milled to produce granules of the desired size.
Tablet Compression: The granules were compressed into tablets using a tablet press. The machine settings were adjusted to control the tablet weight, thickness, and hardness. The tablet properties such as weight variation, hardness, and disintegration time were monitored during compression to ensure consistency. If needed, a coating was applied to the tablets to mask taste, improve stability, or control the release of active ingredients. Coating was done using a pan coater or fluidized bed coater.
Capsule Filling: An appropriate capsule size was chosen based on the bulk density and weight of the blended powder. The powder or granules were filled into empty gelatin or HPMC capsules using an automatic or semi-automatic capsule-filling machine. For additional protection, the capsules were sealed to prevent tampering or leakage.
Under normal conditions, a 500 mg dose would typically be administered multiple times daily. The exact dosage may vary based on factors such as body weight and other relevant conditions other comorbidities, which can be determined by those skilled in the field after reviewing the application. The administration is usually oral, delivered through a tablet or capsule.
Example 8: Stability Study
The following study provides stability data of the present extracts of Zea mays (Baby Corn) silk and husk, prepared by following extraction processes:
1. Hydro-ethanolic extract of Baby Corn Silk (individual) (Batch No. KBDE89725ABD23)
2. Aqueous extract of Baby Corn Silk and Husk (combined) (Batch No. KBDE89725AD23)
3. Supercritical CO2 extract of Baby Corn Silk and Husk (combined) (Batch No. KBDE89725SD23)
Methodology
Stability studies were carried out as per ICH Q1A(R2) guidelines and WHO guidelines for herbal products. Samples were stored in air-tight amber glass containers under:
• Long-term conditions: 25 ± 2 °C / 60 ± 5% RH
• Accelerated conditions: 40 ± 2 °C / 75 ± 5% RH
Analyses were conducted at 0, 3, 6, 12, 24, and 36 months.
Parameters Monitored
• Organoleptic properties (color, odor, appearance)
• Moisture content (Karl Fischer titration)
• pH (aqueous solution)
• Total phenolic content (Folin–Ciocalteu method)
• Flavonoid content (AlCl3 method)
• Marker compounds:
o Hydro-ethanolic extract: Apigenin, Luteolin, Maysin
o Aqueous extract: Phenolic acids (Gallic acid, Ferulic acid, Vanillic acid)
o Supercritical extract: Phytosterols, Fatty acids, Terpenoids
• Microbial load (TAMC, TYMC as per pharmacopeial limits)
• Residual solvents (for hydro-ethanolic extract, GC-MS)
Results:
1. Hydro-ethanolic Extract (Silk only)
• No significant change in organoleptic or physicochemical characteristics up to 36 months.
• Marker compounds (Apigenin, Luteolin, Maysin) retained >95% of initial content under long-term and >90% under accelerated conditions.
• Microbial and residual solvent levels within pharmacopeial limits.
2. Aqueous Extract (Silk + Husk combined)
• Stable up to 36 months with no appreciable change in color, odor, or pH.
• Phenolic acids and total flavonoid content retained >94% at 36 months.
• Microbial load within acceptable pharmacopeial limits throughout study.
3. Supercritical Extract (Silk + Husk combined)
• Retained clarity and oily consistency without phase separation or rancidity.
• Phytosterols, terpenoids, and fatty acids remained >96% stable over 36 months.
• No microbial contamination detected.
The above data demonstrates that the Hydro-ethanolic extract of Baby Corn Silk (individual), the Aqueous extract of Baby Corn Silk and Husk (combined), and the Supercritical CO2 extract of Baby Corn Silk and Husk (combined) maintain chemical, physical, and microbial stability for more than 36 months, confirming their suitability as long-term stable active ingredients for nutraceutical, pharmaceutical, and cosmeceutical formulations.

Table 8: Stability summary table for Hydro-ethanolic Extract of Baby Corn Silk (Individual)
Time Point Appearance Moisture (%) pH (1% sol.) Apigenin (% retention) Luteolin (% retention) Maysin (% retention) Total Phenolics (% retention) Microbial Load (cfu/g) Residual Solvent (ppm)
0 month Brown powder, characteristic odor 3.5 5.8 100 100 100 100 <10² ND
3 months No change 3.6 5.8 99 98 98 98 <10² ND
6 months No change 3.5 5.7 98 97 97 97 <10² ND
12 months No change 3.7 5.7 97 96 96 96 <10² ND
24 months No change 3.8 5.6 96 95 94 95 <10² ND
36 months Stable 3.8 5.6 95 94 93 94 <10² ND

ND – Not Detected

Table 9: Stability summary table for Aqueous Extract of Baby Corn Silk + Husk (Combined)
Time Point Appearance Moisture (%) pH (1% sol.) Gallic Acid (% retention) Ferulic Acid (% retention) Vanillic Acid (% retention) Total Flavonoids (% retention) Microbial Load (cfu/g)
0 month Brown viscous mass, pleasant odor 4.2 6.2 100 100 100 100 <10²
3 months No change 4.3 6.2 99 98 99 98 <10²
6 months No change 4.3 6.1 98 98 98 97 <10²
12 months No change 4.4 6.1 97 97 96 96 <10²
24 months No change 4.4 6.0 96 95 95 95 <10²
36 months Stable 4.5 6.0 95 94 94 94 <10²

Table 10: Stability summary table for Supercritical CO2 Extract of Baby Corn Silk + Husk (Combined)
Time Point Appearance Moisture (%) Peroxide Value (meq/kg) Phytosterols (% retention) Terpenoids (% retention) Fatty Acids (% retention) Microbial Load (cfu/g)
0 month Yellow-brown oil, characteristic odor 1.2 1.5 100 100 100 <10²
3 months No change 1.2 1.6 99 99 99 <10²
6 months No change 1.3 1.7 98 98 98 <10²
12 months No change 1.3 1.8 97 97 97 <10²
24 months No change 1.4 1.9 96 96 96 <10²
36 months Stable 1.5 2.0 96 96 96 <10²

Conclusion
The Hydro-ethanolic extract of Baby Corn Silk (individual), Aqueous extract of Baby Corn Silk and Husk (combined), and Supercritical extract of Baby Corn Silk and Husk (combined) exhibit excellent long-term stability for more than 3 years, with negligible loss of bioactive compounds and no microbial or physicochemical deterioration.
Example 9: Anti-Inflammatory Potential of Synergistic Support Formula (Example No.7) Tablet/Capsule:
Introduction

The following study investigated the anti-inflammatory potential of the synergistic Anti-Inflammatory support (Example No.7) tablet/capsule formulated with Baby Corn Silk or Husk extract, combined with other specific herbal extracts, by evaluating its effect on TNF-a expression in RAW 264.7 murine macrophage cells.
Methods
• Cell Line: RAW 264.7 murine macrophages.
• Induction of Inflammation: Cells were stimulated with lipopolysaccharide (LPS) to induce TNF-a production.
• Treatment: The test formulation was applied at varying concentrations.
• Assessment: Anti-inflammatory potential was measured by quantifying TNF-a production using enzyme-linked immunosorbent assay (ELISA). Cytotoxicity was evaluated by MTT assay to ensure safety at effective doses.
Results
The study assessed both cytotoxicity and anti-inflammatory activity as follows:
Table 11: Cytotoxicity (Cell Viability %)
Concentration (µg/mL) Cell Viability (%)
1000 88.67
500 91.25
250 93.08
125 95.74
62.5 97.22
31.25 98.63
15.625 99.23
7.8 99.53
Table 12: Anti-inflammatory Effect (TNF-a Inhibition)
Sample Inhibition of TNF-a (%)
LPS + 500 µg/mL 57.33
LPS + 250 µg/mL 31.33
LPS Control 0

Discussion
The results demonstrate that the synergistic formulation effectively suppressed TNF-a production in LPS-stimulated RAW 264.7 macrophages in a concentration-dependent manner. At 500 µg/mL, TNF-a inhibition reached 57.33%, while 250 µg/mL produced 31.33% inhibition. Importantly, the cytotoxicity assay confirmed that the formulation remained non-toxic, with cell viability above 85% even at the maximum tested concentration of 1000 µg/mL.
Conclusion
This study establishes that the synergistic anti-inflammatory support formulation (Example No.7) comprising Baby Corn Silk or Husk extract in combination with other herbal extracts exhibited significant anti-inflammatory activity without notable cytotoxic effects. The observed inhibition of TNF-a indicates potential therapeutic application of the composition in the prevention and management of inflammatory and related chronic conditions.
Example 10: In Vitro Anti-Adipogenesis Activity
Introduction
The following in vitro study evaluated the anti-adipogenesis activity of the present synergistic weight loss support tablet/capsule (Example No.2), formulated with Baby Corn Silk or Husk extract combined with other specific herbal extracts. The study assessed lipid accumulation in 3T3-L1 pre-adipocytes using Oil Red O staining, with Orlistat included as a standard control.
Materials and Methods
• Cell Line: 3T3-L1 mouse embryo fibroblast pre-adipocytes
• Differentiation Induction: Standard MDI cocktail (IBMX, dexamethasone, insulin)
• Treatment: Cells treated with Example No.2 formulation at low (25 µg/mL), mid (50 µg/mL), and high (100 µg/mL) doses, as well as Orlistat (10 µM) as the standard control, during differentiation
• Assessment: Lipid accumulation quantified after Oil Red O staining by spectrophotometric absorbance measurement
Results
Oil Red O staining revealed that the Example No.2 formulation inhibited lipid droplet formation in a dose-dependent manner compared to differentiated control cells. Orlistat, the standard control, also exhibited significant inhibition of lipid accumulation.
Table 13: Effect of Example No. 2 Formulation and Orlistat on Lipid Accumulation in 3T3-L1 Cells
Treatment Group Relative Lipid Accumulation (% of Control)
Differentiated Control 100
Example No.2 – Low Dose (25 µg/mL) 78
Example No.2 – Mid Dose (50 µg/mL) 55
Example No.2 – High Dose (100 µg/mL) 32
Orlistat (10 µM) 28

Discussion:
The Example No.2 formulation demonstrated significant anti-adipogenic activity by reducing lipid accumulation in 3T3-L1 pre-adipocytes in a dose-dependent manner. The high dose (100 µg/mL) achieved a reduction to ~32% of control, while Orlistat (10 µM) reduced lipid accumulation to ~28% of control. This indicates that the formulation provides comparable efficacy to the pharmaceutical standard.
Conclusion:
The study establishes that A synergistic weight loss support tablet/capsule (Example No.2), formulated with Baby Corn Silk or Husk extract combined with specific herbal extracts, exerts potent anti-adipogenesis activity in vitro. Its inhibitory effect on lipid accumulation was dose-dependent and comparable to Orlistat, the standard anti-obesity control. These results support its potential application as a natural therapeutic candidate for weight management and obesity prevention.
Example 11: In Vitro Cytotoxicity of a Synergistic Anti-Cancer Supplement Formulation (Example No.3) Against Breast and Prostate Cancer Cells
Assay: MTT Assay
Cell Lines Tested: MCF-7 (Human Breast Adenocarcinoma), LNCaP (Human Prostate Adenocarcinoma)
Evidence 1: Breast Cancer Cells (MCF-7)
Experimental Design:
• Cells seeded at 1×104/well in 96-well plate.
• Treated with the synergistic anti-cancer supplement tablet/capsule formulated with Baby Corn Silk or Husk extract, combined with other specific herbal extracts (Example 3) at concentrations of 5–500 µg/mL.
• Incubation periods: 24 h, 48 h, 72 h.
• MTT assay performed; absorbance at 570 nm recorded.
Table 14
Concentration (µg/mL) 24h 48h 72h
0.0 99.99 99.99 99.99
5.0 92.37 88.19 80.49
10.0 78.21 89.11 67.73
25.0 79.68 74.28 55.15
50.0 66.91 69.68 40.94
100.0 70.61 50.62 33.6
200.0 62.17 48.15 25.27
300.0 65.26 39.21 23.1
400.0 65.4 36.98 19.62
500.0 66.97 28.99 15.26

Interpretation:
- IC50 ˜ 100 µg/mL (48 h).
- IC50 ˜ 50 µg/mL (72 h).
- Maximum inhibition at 500 µg/mL reduced viability to ~15%.
Result: The Dose- Response Curve for Breast Cancer Cells (MCF-7) is depicted in Figure 2.
Evidence 2: Prostate Cancer Cells (LNCaP)
Experimental Design:
• Cells seeded at 2×104/well in 96-well plate.
• Treated with a synergistic anti-cancer supplement tablet/capsule formulated with Baby Corn Silk or Husk extract, combined with other specific herbal extracts (Example 3) at concentrations of 5–500 µg/mL.
• Incubation periods: 24 h, 48 h, 72 h.
• MTT assay performed; absorbance at 570 nm recorded.
Table 15
Concentration (µg/mL) 24h 48h 72h
0.0 99.99 99.99 99.99
5.0 92.56 77.98 81.85
10.0 75.19 73.91 54.43
25.0 74.36 77.76 54.86
50.0 73.6 52.01 33.22
100.0 65.87 48.94 30.71
200.0 76.27 46.89 27.13
300.0 61.14 42.22 22.12
400.0 55.12 39.24 21.96
500.0 55.63 30.86 18.35

Interpretation:
- IC50 ˜ 200 µg/mL (48 h).
- IC50 ˜ 50 µg/mL (72 h).
- Maximum inhibition at 500 µg/mL reduced viability to ~18%.
Result: The Dose- Response Curve for Prostate Cancer Cells (LNCaP) is depicted in Figure 3
Evidence 3: Comparative Analysis

Table 16
Parameter MCF-7 (Breast Cancer) LNCaP (Prostate Cancer)
24 h IC50 >100 µg/mL >200 µg/mL
48 h IC50 ~100 µg/mL ~200 µg/mL
72 h IC50 ~50 µg/mL ~50 µg/mL
Max inhibition (500 µg/mL, 72 h) ~85% ~82%
Conclusion
The synergistic anti-cancer supplement tablet/capsule formulated with Baby Corn Silk or Husk extract, combined with other specific herbal extracts (Example 3), demonstrated significant dose- and time-dependent cytotoxicity in vitro. Both breast and prostate cancer cell lines showed strong inhibition, with IC50 values converging to ~50 µg/mL at 72 h.
Example 12: In vitro study evaluating the glucose uptake activity of the synergistic Anti-Diabetic support tablet/capsule (Example No.1)
Introduction
The following in vitro study evaluated the glucose uptake activity of the synergistic Anti-Diabetic support tablet/capsule (Example No.1), formulated with Baby Corn Silk or Husk extract combined with other specific herbal extracts. The study assessed glucose uptake in L6 rat skeletal muscle cells, with Metformin as the positive control.
Materials and Methods
• Cell Line: Rat skeletal muscle (L6) cell line
• Differentiation: Myoblasts were differentiated into myotubes over 7–10 days
• Treatment: Differentiated cells were treated with Example No.1 formulation at low (25 µg/mL), mid (50 µg/mL), and high (100 µg/mL) doses, as well as Metformin (10 µM) as a standard control
• Assay: Glucose uptake was measured using 2-deoxyglucose uptake assay spectrophotometrically
Results
The Example No.1 formulation significantly enhanced glucose uptake in L6 cells in a dose-dependent manner. The high dose exhibited effects comparable to Metformin, the positive control.
Table 17: Effect of Example No.1 Formulation and Metformin on Glucose Uptake in L6 Cells
Treatment Group Glucose Uptake (% of Control)
Control 100
Example No.1 – Low Dose (25 µg/mL) 118
Example No.1 – Mid Dose (50 µg/mL) 142
Example No.1 – High Dose (100 µg/mL) 165
Metformin (10 µM) 170

Discussion
The Example No.1 formulation demonstrated dose-dependent glucose uptake enhancement in L6 myotubes. At 100 µg/mL, the formulation achieved ~165% of control, comparable to Metformin at 170%. These findings suggest activation of insulin-mediated pathways such as GLUT4 translocation or AMPK signaling.
Conclusion
The study establishes that A synergistic Anti-Diabetic support tablet/capsule (Example No.1), formulated with Baby Corn Silk or Husk extract combined with other herbal extracts, significantly enhances glucose uptake in L6 skeletal muscle cells. Its effect was dose-dependent and comparable to Metformin, supporting its potential as a natural anti-diabetic therapeutic agent.

Although the invention has been described in detail in the foregoing for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention except as it may be limited by the claims.
,CLAIMS:1. A herbal composition comprising extracts of baby corn silk in an amount in the range of 1.2 to 75 %, baby corn husk in an amount in the range of 1.2 to 75 %, either alone or in combination thereof.
2. The herbal composition as claimed in Claim 1, wherein the composition comprises extracts of baby corn silk in an amount of 30 %, baby corn husk in an amount of 14 %, either alone or in combination thereof.
3. The herbal composition as claimed in Claim 1, wherein the extracts are standardized extracts.
4. The herbal composition as claimed in Claim 1, wherein the composition may comprise of acceptable excipients or additives selected from binders, diluents, surfactants, emulsifiers, carriers, lubricants, solvents, pH adjusters, colorants, essential oils, anti-caking agent, dispersing agent and the like, alone or mixtures thereof.
5. The herbal composition as claimed in Claim 1, wherein the composition may comprise extracts of herbs selected from:
i. Trigonella Foenum-Graecum (Fenugreek) extract in an amount in the range of 1.2 to 75 %, more preferably 18 %;
ii. Syzygium Cumini (Jamun) extract in an amount in the range of 0.5 to 30 %, more preferably 4.8 %;
iii. Berberis Aristata (Indian Barberry); extract in an amount in the range of 1.2 to 50 %, more preferably 18 %;
iv. Aegle Marmelos (Bael) extract in an amount in the range of 1.2 to 50 %, more preferably 24 %;
v. Ocimum Sanctum (Holy Basil or Tulsi) ) extract in an amount in the range of 1.5 to 45 %, more preferably 23.1 %;
vi. Cinnamomum Verum (True Cinnamon) extract in an amount in the range of 0.5 to 35 %, more preferably 4 %;
vii. Gymnema Sylvestre extract in an amount in the range of 0.5 to 35 %, more preferably 7 %;
viii. Momordica Charantia (Bitter Melon) extract in an amount in the range of 0.5 to 35 %, more preferably 10 %;
ix. Curcuma Longa (Turmeric) extract in an amount in the range of 0.5 to 35 %, more preferably 6 %;
x. Pterocarpus Marsupium extract in an amount in the range of 0.5 to 35 %, more preferably 8 %;
xi. Moringa Oleifera extract in an amount in the range of 0.5 to 35 %, more preferably 4.2 %;
xii. Tinospora Cardifolia (Guduchi or Giloy) extract in an amount in the range of 1.2 to 30 %, more preferably 6 %;
xiii. Neem Leaf (Azadirachta indica) extract in an amount in the range of 0.5 to 35 %, more preferably 16 %;
xiv. Andrographis Paniculata (Kalmegh) extract in an amount in the range of 1.5 to 40 %, more preferably 8 %; and
xv. Piper Longum (Long Pepper) extract in an amount in the range of 0.01 to 30 %, more preferably 1.2 %.
6. The herbal composition as claimed in Claim 1, wherein the extracts of baby corn silk and baby corn husk may be obtained by the processes selected from ethanolic extraction process, hydro-ethanolic extraction method, aqueous extraction process, supercritical fluid extraction (SFE) process, ultrasonic-assisted extraction process, and microwave-assisted extraction (MAE) process alone or combination thereof.
7. The herbal composition as claimed in Claim 6, wherein the extracts of baby corn silk and baby corn husk may be obtained by ethanolic extraction process comprising the steps of :
i. Collecting the fresh baby corn silk and baby corn husk from mature corn plants;
ii. Rinsing the baby corn silk and husk thoroughly followed by drying the cleaned materials using air-drying or a low-temperature drying process to reduce moisture content while preserving bioactive compounds;
iii. Grinding the dried silk and husk into a coarse powder to enhance the surface area for extraction;
iv. Preparing a 70% to 90% concentrated ethanol solution based on the desired extraction efficiency;
v. Extracting individually by utilizing each product as obtained in step iii:
1. Baby Corn Silk: Combining the powdered baby corn silk with ethanol in an extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v); and
2. Baby Corn Husk: Mixing the powdered husk with ethanol in a separate extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
vi. Extracting by combining baby corn silk and baby corn husk in step (iii) by:
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with ethanol and maintaining a solvent-to-material ratio of 5:1 to 10:1 (v/v);
2. Stirring continuously or agitating the mixture as obtained in step (1) of step (vi) to promote effective extraction of bioactive compounds; and
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a duration of 4 to 24 hours;
vii. Filtering the mixture as obtained in step (v) and (vi) using filter paper or a centrifuge to separate the liquid extract from the solid residues;
viii. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
ix. Purifying the concentrated extract as obtained in step (viii) using techniques such as column chromatography or high-performance liquid chromatography (HPLC) to isolate specific bioactive compounds; and
x. Drying the purified extract as obtained in step (ix) to obtain a stable powder or concentrated liquid.
8. The herbal composition as claimed in Claim 6, wherein the extracts of baby corn silk and baby corn husk may be obtained by hydro-ethanolic extraction method comprising the steps of :
i. Obtaining fresh baby corn silk and baby corn husk from mature corn plants;
ii. Rinsing the baby corn silk and husk thoroughly;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing a hydro-ethanolic solvent by mixing water and a 30% to 70% concentrated ethanol solution based on the desired extraction efficiency;
vi. Extracting individually by utilizing each product as obtained in step iv:
1. Baby Corn Silk: Combining the powdered baby corn silk with the hydro-ethanolic solvent in an extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
2. Baby Corn Husk: Mixing the powdered husk with the hydro-ethanolic solvent in a separate extraction vessel in a solvent-to-material ratio between 5:1 and 10:1 (v/v);
vii. Extracting by combining each product obtained in step (iv):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the hydro-ethanolic solvent and maintaining a solvent-to-material ratio of 5:1 to 10:1 (v/v);
2. Stirring continuously or agitating the mixture to enhance the extraction of bioactive compounds;
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a period of 4 to 24 hours depending on the efficiency of extraction;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as column chromatography or high-performance liquid chromatography (HPLC) to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated liquid.
9. The herbal composition as claimed in Claim 6, wherein the extracts of baby corn silk and baby corn husk may be obtained by aqueous extraction process comprising the steps of :
i. Obtaining fresh baby corn silk and husk from mature corn plants;
ii. Rinsing the baby corn silk and husk thoroughly;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Using distilled or purified water as the extraction solvent;
vi. Extracting individually by utilizing each product as obtained in step (iv):
1. Baby Corn Silk: Combining the powdered baby corn silk with water in an extraction vessel in a solvent-to-material ratio in between 10:1 and 20:1 (v/v);
2. Baby Corn Husk: Mixing the powdered husk with water in a separate extraction vessel in a solvent-to-material ratio in between 10:1 and 20:1 (v/v);
vii. Extracting by combining each product obtained in step (iv):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the hydro-ethanolic solvent and maintaining a solvent-to-material ratio of 10:1 to 20:1 (v/v);
2. Stirring continuously or agitating the mixture to enhance the extraction of bioactive compounds;
3. Conducting the extraction at room temperature or slightly elevated temperatures such as 40-60°C for a period of 1 to 4 hours;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract using a rotary evaporator or similar equipment to remove excess ethanol for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as liquid- liquid extraction or column chromatography to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated liquid.
10. The herbal composition as claimed in Claim 6, wherein the extracts of baby corn silk and baby corn husk may be obtained by Supercritical Fluid Extraction (SFE) process comprising the steps of :
i. Obtaining fresh baby corn silk and husk from mature corn plants;
ii. Rinsing the baby corn silk and husk thoroughly;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Using supercritical carbon dioxide (CO2) as the extraction fluid;
vi. Extracting individually by utilizing each product as obtained in step (iv):
1. Baby Corn Silk: Placing the powdered baby corn silk in the extraction chamber of the SFE apparatus and setting the extraction parameters, such as pressure and temperature as 73.8 bar for CO2 and around 31°C to achieve supercritical conditions;
2. Baby Corn Husk: Placing the powdered husk in a separate extraction chamber and setting the appropriate parameters for supercritical extraction;
vii. Combining the powdered baby corn silk and baby corn husk of step (iv) in a single extraction chamber, adjusting the SFE parameters such as temperature between 31°C and 60°C; pressure between 70 bar and 300 bar for 1 to 4 hours;
viii. Concentrating the filtered extract using techniques such as evaporation or solvent removal for obtaining a more concentrated extract;
ix. Purifying the concentrated extract as obtained in step (viii) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
x. Drying the purified extract as obtained in step (ix) to obtain a stable powder or concentrated liquid.
11. The herbal composition as claimed in Claim 6, wherein the extracts of baby corn silk and baby corn husk may be obtained by Ultrasonic-Assisted Extraction process comprising the steps of :
i. Obtaining fresh baby corn silk and husk from mature corn plants;
ii. Rinsing the baby corn silk and husk thoroughly;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing an appropriate solvent for extraction, such as water, ethanol, or a hydro-ethanolic mixture, depending on the solubility of the desired bioactive compounds;
vi. Extracting individually by utilizing each product as obtained in step (iv):
1. Baby Corn Silk: combining the powdered baby corn silk with the prepared solvent in a ratio of 1:4 in an extraction vessel;
2. Baby Corn Husk: mixing the powdered husk with the solvent in a ratio of 1:4 in a separate extraction vessel;
vii. Extracting by combining each product as obtained in step (iv):
1. Mixing the powdered baby corn silk and husk in a single extraction vessel with the chosen solvent;
2. Performing ultrasonic-assisted extraction by placing the extraction vessel in an ultrasonic bath or using an ultrasonic probe to apply ultrasonic waves to the mixture by using ultrasonic frequencies range from 20 kHz to 40 kHz for 15 to 60 minutes depending on the efficiency of extraction and the nature of the material, maintaining the extraction temperature at ambient or slightly elevated temperatures to optimize extraction without degrading bioactive compounds, and agitating the mixture during ultrasonic treatment to further enhance extraction efficiency;
viii. Filtering the mixture obtained in step (vi) and (vii) using filter paper or centrifuging to separate the liquid extract from the solid residues;
ix. Concentrating the filtered extract of step (viii) using a rotary evaporator or solvent removal for obtaining a more concentrated extract;
x. Purifying the concentrated extract as obtained in step (ix) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
xi. Drying the purified extract as obtained in step (x) to obtain a stable powder or concentrated.
12. The herbal composition as claimed in Claim 6, wherein the extracts of baby corn silk and baby corn husk may be obtained by Microwave-Assisted Extraction (MAE) process comprising the steps of :
i. Obtaining fresh baby corn silk and husk from mature corn plants;
ii. Rinsing the baby corn silk and husk thoroughly;
iii. Drying the cleaned silk and husk using air-drying or low-temperature drying methods to reduce moisture content while preserving the bioactive compounds;
iv. Grinding the dried silk and husk into a coarse powder to increase the surface area for efficient extraction;
v. Preparing an appropriate solvent for extraction, such as water, ethanol, or a hydro-ethanolic mixture, based on the solubility of the bioactive compounds;
vi. Extracting individually by utilizing each product as obtained in step (iv):
1. Baby Corn Silk: placing the powdered baby corn silk in a microwave-assisted extraction vessel and adding the prepared solvent in a ratio of 1:4;
2. Baby Corn Husk: placing the powdered husk in a separate extraction vessel with the solvent in a ratio of 1:4;
vii. Mixing the powdered baby corn silk and husk of step (iv) in a single extraction vessel with the chosen solvent as obtained in step (v);
viii. Performing Microwave-Assisted Extraction by placing the extraction vessel in a microwave extractor, adjusting the microwave power between 300 to 800 watts depending on the extraction requirements for 5 to 30 minutes depending on the material and desired efficiency, and maintaining the extraction temperature at optimal levels, usually between 50°C and 100°C to prevent degradation of bioactive compounds;
ix. Stirring the mixture during microwave treatment to ensure even exposure to microwave energy and improve extraction efficiency;
x. Allowing the mixture to cool to room temperature after microwave treatment;
xi. Filtering the mixture of step (x) using filter paper or centrifuging to separate the liquid extract from the solid residues;
xii. Concentrating the filtered extract using a rotary evaporator or solvent removal for obtaining a more concentrated extract;
xiii. Purifying the concentrated extract as obtained in step (xii) using techniques such as chromatography or filtration to isolate specific bioactive compounds; and
xv. Drying the purified extract as obtained in step (xiii) to obtain a stable powder or concentrated liquid.
13. The herbal composition as claimed in Claim 1, wherein the composition may be formulated as tablets, capsules, powders, granules, liquids, rings, solids, tablets, pastes, soft, jelly and rod types.

14. A formulation comprising the herbal composition as claimed in Claim 1 along with acceptable excipients.

15. Use of the herbal composition as claimed in any one of the preceding claims for metabolic and chronic diseases such as for the management and prevention of diabetes, inflammation, cancer, obesity, and other related disorders.
16. A method for managing and preventing of diabetes, inflammation, cancer, obesity, and other related disorders, comprising administering a therapeutically effective amount of the composition claimed in any one of the preceding claims to a subject in need thereof.