Description:FIELD OF INVENTION
The present invention relates to the field of herbal medicinal formulations, particularly compositions with antiviral and antibacterial properties. More specifically, it pertains to a herbal formulation named Kadhaayu, composed of bioactive plant-derived ingredients for the treatment of respiratory infections such as flu, sore throat, and nasal congestion.
BACKGROUND OF THE INVENTION
Respiratory infections such as the common cold, influenza, and viral sore throat remain a persistent global health burden, particularly affecting children, the elderly, and immunocompromised individuals. These infections are predominantly caused by viruses like Influenza A, SARS-CoV-2, and Human rhinovirus, as well as bacterial pathogens such as Streptococcus pneumoniae, Streptococcus pyogenes, and Moraxella catarrhalis. Current treatment strategies primarily rely on synthetic antiviral and antibiotic drugs, which often come with limitations including the risk of antibiotic resistance, undesirable side effects, and high costs. Moreover, many of these medications provide only symptomatic relief rather than addressing the root cause of the infection. The widespread use of synthetic compounds has also raised concerns about long-term toxicity, particularly when used during recurrent or seasonal infections. There remains a growing demand for safe, affordable, and holistic alternatives that offer both curative and preventive benefits without compromising safety.
Kadhaayu is designed to target the core molecular mechanisms of respiratory infections by inhibiting key viral and bacterial proteins essential for pathogen survival and replication. The invention solves the problem of inefficacy and toxicity associated with conventional therapies by combining multiple plant extracts, each rich in bioactive compounds like Withaferin A, Curcumin, Piperine, and Emblicanin B, which exhibit strong antimicrobial, anti-inflammatory, immunomodulatory, and antioxidant activities. The formulation has been optimized to ensure maximum efficacy, bioavailability, and safety. Kadhaayu thus offers a promising alternative to synthetic drugs, addressing both the symptoms and underlying causes of respiratory infections, while also strengthening the body’s natural immune defenses.
OBJECTS OF THE INVENTION
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative
An object of the present disclosure is to have broad-spectrum activity against both viral and bacterial pathogens.
Another object of the present disclosure is natural composition with no synthetic additives, minimizing side effects.
Still another object of the present disclosure is Synergistic effect of multiple bioactive compounds for enhanced therapeutic efficacy.
Another object of the present disclosure is having various delivery options including decoction, syrup, capsule, tablet, and instant tea.
Still another object of the present disclosure is having strong binding affinity against target proteins, enhancing pathogen inhibition.
Still another object of the present disclosure is having favorable pharmacokinetics with good absorption, distribution, and metabolism.
Yet another object of the present disclosure is non-toxic with minimal risk of adverse effects based on in silico predictions.
Yet another object of the present disclosure is having effective immune support, making it suitable for prevention and treatment of infections.

Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY OF THE INVENTION
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.

The present invention is generally relates to a herbal formulation, 'Kadhaayu,' composed of extracts from eight key plants known for their therapeutic properties. These include Withania somnifera, Curcuma longa, Emblica officinalis, Piper nigrum, Convolvulus prostratus, Glycyrrhiza glabra, Echinacea purpurea, and optionally other herbs.
An embodiment of the present invention is the formulation contains bioactive compounds like Withaferin A, Curcumin, Emblicanin A & B, Piperine, Convolvidine, Glycyrrhizin, and Chicoric acid. These compounds synergistically enhance the formulation's antimicrobial and antiviral properties.
Another embodiment of the invention is kadhaayu' is effective against a range of pathogens, including viruses like Influenza A, SARS-CoV-2, and Human rhinovirus, as well as bacteria like Moraxella catarrhalis, Streptococcus pneumoniae, and Streptococcus pyogenes.
Yet another embodiment of the invention is the formulation is adaptable to various delivery forms, including decoction, syrup, capsule, tablet, and instant tea. This ensures convenient administration tailored to patient preferences and specific use cases.
Yet another embodiment of the invention is in silico studies show that the active compounds in the formulation exhibit binding affinity scores ranging from –4.2 to –10.3 kcal/mol against target proteins. This suggests a strong potential for inhibiting pathogen replication and modulating immune responses.
Yet another embodiment of the invention is the 'Kadhaayu' formulation is particularly useful for treating viral and bacterial infections, especially respiratory conditions. It can also serve as a preventive treatment to boost immunity, particularly in immunocompromised individuals or as a supplementary therapy for overall health maintenance.
Yet another embodiment of the invention is the nutraceutical Kadhaayu composition comprising
a) Withania somnifera (Ashwagandha) root extract in an amount of 100 to 120 mg;
b) Curcuma longa (Turmeric) rhizome extract in an amount of 100 to 150 mg;
c) Cinnamomum zeylanicum (Cinnamon) bark extract in an amount of 50 to 80 mg;
d) Garcinia mangostana (Mangosteen) pericarp extract in an amount of 100 to 180 mg;
e) Camellia sinensis (Green Tea) leaf extract in an amount of 50 to 100 mg;
f) Piper nigrum (Black Pepper) fruit extract in an amount of 25 to 50 mg;
g) Zingiber officinale (Ginger) rhizome extract in an amount of 50 to 80 mg;
h) Ocimum sanctum (Tulsi) leaf extract in an amount of 50 to 80 mg;
i) Convolvulus prostratus (Shankpushpi) whole plant extract in an amount of 50 to 80 mg;
j) Coriandrum sativum (Coriander) seed extract in an amount of 50 to 70 mg;
k) Syzygium aromaticum (Clove) bud extract in an amount of 25 to 35 mg;
l) Myristica fragrans (Nutmeg) seed extract in an amount of 25 to 35 mg;
m) Glycyrrhiza glabra (Mulethi) root extract in an amount of 50 to 60 mg;
n) Adhatoda vasica (Adulsa) leaf extract in an amount of 50 to 70 mg;
o) Echinacea purpurea (Echinacea) root extract in an amount of 50 to 60 mg;
p) Bacopa monnieri (Brahmi) whole plant extract in an amount of 50 to 60 mg;
q) Ferula asafoetida (Asafoetida) resin in an amount of 25 to 30 mg; and
r) Emblica officinalis (Amla) fruit extract in an amount of 100 to 150 mg.
Yet another embodiment of the invention is the method of preparing a nutraceutical composition comprising the steps of:
a) washing and drying the said herbs under conditions selected from shade drying for thermolabile constituents and oven drying at 40–50 °C for robust plant parts;
b) pulverizing the dried herbs into coarse powder of 40–60 mesh size;
c) subjecting the powdered herbs to extraction processes selected from (i) hydro-alcoholic extraction of roots and rhizomes by Soxhlet, (ii) aqueous infusion of leaves at 80 °C, (iii) hydro-ethanolic percolation of barks and seeds, (iv) direct pulverization of resins, and (v) cold maceration of fruits;
d) filtering the resulting extracts; concentrating the filtrates under reduced pressure at about 45 °C;
e) drying the concentrated extracts by spray drying to obtain free-flowing powders having a moisture content below 5%;
f) blending the dried extracts uniformly in a stainless-steel blender;
g) confirming homogeneity by thin layer chromatography fingerprinting; and packing the final blend as a Kadha base powder in moisture-proof containers for storage at a temperature of about 25 °C and relative humidity of not more than 40%.
Yet another embodiment of the invention is wherein the extract blend is formulated into a dosage form selected from (i) tablets, wherein the blend is granulated with microcrystalline cellulose, starch, and a natural binder such as acacia gum, compressed into about 500 mg units and optionally coated for stability; (ii) capsules, wherein the dried extracts are filled into vegetarian hydroxypropyl methylcellulose (HPMC) capsules at about 500 mg per capsule for improved patient compliance and portability; or (iii) a decoction (Kadha), wherein about 5 g of the powder is boiled in about 150 mL of water until the volume reduces to about 50 mL, with a recommended dosage of one cup administered twice daily.
Yet another embodiment of the invention is the wherein the formulation exhibits (i) DPPH radical inhibition of about 82% at 200 µg/mL; (ii) ABTS radical inhibition of about 78% at 150 µg/mL; (iii) antibacterial activity against E. coli with a zone of inhibition of about 20 mm at 100 µg/mL; (iv) antibacterial activity against S. aureus with a zone of inhibition of about 22 mm at 100 µg/mL; (v) protein denaturation inhibition of about 75% at 300 µg/mL; and (vi) MTT proliferation inhibition of about 38% at 150 µg/mL.

DETAILED DESCRIPTION OF THE INVENTION
The following description is of exemplary embodiments only and is not intended to limit the scope, applicability or configuration of the invention in any way. Rather, the following description provides a convenient illustration for implementing exemplary embodiments of the invention. Various changes to the described embodiments may be made in the function and arrangement of the elements described without departing from the scope of the invention.

The present invention relates to he present invention relates to a novel herbal formulation, 'Kadhaayu,' which consists of extracts from eight traditional plant species known for their medicinal properties. This formulation exhibits potent antimicrobial and antiviral activities, designed to combat a broad range of pathogens, including Influenza A, SARS-CoV-2, Human rhinovirus, Moraxella catarrhalis, Streptococcus pneumoniae, and Streptococcus pyogenes. The composition of 'Kadhaayu' contains active compounds such as Withaferin A from Withania somnifera (Ashwagandha), Curcumin from Curcuma longa (Turmeric), Emblicanin A and B from Emblica officinalis (Amla), Piperine from Piper nigrum (Black Pepper), Convolvidine from Convolvulus prostratus (Shankhpushpi), Glycyrrhizin from Glycyrrhiza glabra (Licorice), and Chicoric acid from Echinacea purpurea (Purple Coneflower), with the option of including additional herbs. These compounds work synergistically, contributing to the formulation’s effectiveness in reducing pathogen load and supporting immune function.

In addition to its antimicrobial and antiviral activity, the formulation demonstrates favorable pharmacokinetic properties, including high bioavailability and minimal toxicity. The composition has been shown to exhibit binding affinity scores in the range of –4.2 to –10.3 kcal/mol against target proteins, as determined by molecular docking studies, indicating its potential to effectively interact with key proteins involved in pathogen replication and immune modulation. In silico predictions of Absorption, Distribution, Metabolism, and Excretion (ADME) properties suggest that the formulation is well-absorbed and metabolized, with a favorable safety profile.
The formulation is versatile and can be administered in various forms, including decoction, syrup, capsule, tablet, or instant tea, providing flexibility to meet patient preferences and needs. The herbal composition is non-toxic based on in silico toxicity prediction models, making it a safe option for long-term use in preventing and treating infections. This formulation is particularly beneficial for treating viral and bacterial infections, especially those affecting the respiratory system, and may also serve as a supplementary therapy to boost immune function and prevent secondary infections in immunocompromised individuals.

The present invention is advantageous due to its broad-spectrum antimicrobial and antiviral activity, its natural composition that minimizes side effects, and its ability to enhance the bioavailability and therapeutic effects of other active compounds. It represents a promising therapeutic approach to addressing the growing concern of antimicrobial resistance and the need for alternative antiviral treatments.
BIOLOGICAL SOURCE:
Ingredient Latin Name Family Verified Botanical Source Country of Origin
Ashwagandha Withania somnifera Solanaceae Roots, authenticated India
Turmeric Curcuma longa Zingiberaceae Rhizomes Kerala, India
Cinnamon Cinnamomum zeylanicum Lauraceae Bark Sri Lanka
Mangosteen Garcinia mangostana Clusiaceae Pericarp North-East India
Green Tea Camellia sinensis Theaceae Leaves Assam, India
Black Pepper Piper nigrum Piperaceae Fruits Kerala, India
Ginger Zingiber officinale Zingiberaceae Rhizomes India
Tulsi Ocimum sanctum Lamiaceae Leaves India
Shankpushpi Convolvulus prostratus Convolvulaceae Whole plant India
Coriander Coriandrum sativum Apiaceae Seeds India
Clove Syzygium aromaticum Myrtaceae Buds Indonesia
Nutmeg Myristica fragrans Myristicaceae Seeds India
Mulethi Glycyrrhiza glabra Fabaceae Roots India
Adulsa Adhatoda vasica Acanthaceae Leaves India
Echinacea Echinacea purpurea Asteraceae Roots Europe (Imported)
Brahmi Bacopa monnieri Plantaginaceae Whole plant India
Asafoetida Ferula asafoetida Apiaceae Resin Afghanistan
Amla Emblica officinalis Phyllanthaceae Fruits India

EXAMPLE 1: COMPOSITION OF KADAYU
Sr. Ingredient Latin Name Qty (mg) Pharmacological Relevance
1 Ashwagandha Withania somnifera 100–120 Adaptogenic, anti-stress, anxiolytic, improves stamina
2 Turmeric Curcuma longa 100–150 Anti-inflammatory (curcumin), antioxidant, anticancer
3 Cinnamon Cinnamomum zeylanicum 50–80 Antidiabetic, antimicrobial, circulatory stimulant
4 Mangosteen Garcinia mangostana 100–180 Rich in xanthones, potent antioxidant, anti-inflammatory
5 Green Tea Camellia sinensis 50–100 Contains catechins, cardioprotective, metabolic regulator
6 Black Pepper Piper nigrum 25–50 Enhances bioavailability, digestive stimulant
7 Ginger Zingiber officinale 50–80 Anti-nausea, anti-inflammatory, enhances circulation
8 Tulsi Ocimum sanctum 50–80 Immunomodulatory, antiviral, adaptogenic
9 Shankpushpi Convolvulus prostratus 50–80 Neuroprotective, cognition-enhancing
10 Coriander Coriandrum sativum 50–70 Antioxidant, digestive, detoxifying
11 Clove Syzygium aromaticum 25–35 Antimicrobial, analgesic, antioxidant
12 Nutmeg Myristica fragrans 25–35 Antimicrobial, carminative, nervine relaxant
13 Mulethi Glycyrrhiza glabra 50–60 Expectorant, immunomodulatory, anti-ulcer
14 Adulsa Adhatoda vasica 50–70 Respiratory supportive, bronchodilator
15 Echinacea Echinacea purpurea 50–60 Immune-stimulant, antiviral, anti-inflammatory
16 Brahmi Bacopa monnieri 50–60 Memory enhancing, neuroprotective
17 Asafoetida Ferula asafoetida 25–30 Digestive, antimicrobial, antispasmodic
18 Amla Emblica officinalis 100–150 Rich in vitamin C, antioxidant, hepatoprotective
The extract blend can be formulated into different dosage forms such as tablets, capsules, and decoction. For tablets, the blend is granulated with microcrystalline cellulose, starch, and a natural binder like acacia gum, compressed into 500 mg units, and coated for stability. In capsule form, the dried extracts are filled into vegetarian HPMC capsules at 500 mg per capsule, offering better patient compliance and portability. As a traditional decoction (Kadha), 5 g of the powder is boiled in 150 mL of water until the volume reduces to 50 mL, with a recommended dosage of one cup twice daily.
Table 2. Protein targets used in the antioxidant analysis of berries
S. No. Organism Protein PDB ID
1 Influenza A virus Hemagglutinin (HA) 2VIU
Neuraminidase 1NNB
2 SARS-CoV-2 Nucleocapsid (N) protein 7F2B
3 Human rhinovirus Coat Protein (SUBUNIT VP1) 1HRI
4 Moraxella catarrhalis Phosphoethanolamine transferase 6BNC
5 Streptococcus pneumoniae PfbA (plasmin- and fibronectin-binding protein A) 4MR0
6 Streptococcus pyogenes Chemokine protease C 5XYA
M protein 2OTO

In the present invention, the selection of target proteins was step in establishing the therapeutic relevance of the Kadhaayu formulation. The targeted proteins are associated with viral and bacterial pathogens that are commonly responsible for respiratory ailments such as flu, sore throat, and nasal congestion. These include proteins from viruses like Influenza A, SARS-CoV-2, and Human rhinovirus, as well as bacterial strains like Moraxella catarrhalis, Streptococcus pneumoniae, and Streptococcus pyogenes. The specific viral proteins selected for this study are Hemagglutinin (HA) and Neuraminidase from Influenza A virus, the Nucleocapsid (N) protein from SARS-CoV-2, and the Coat Protein (VP1 subunit) from Human rhinovirus. For bacterial pathogens, the selected targets include Phosphoethanolamine transferase from Moraxella catarrhalis, PfbA (plasmin- and fibronectin-binding protein A) from Streptococcus pneumoniae, and Chemokine protease C and M protein from Streptococcus pyogenes.

These proteins were chosen based on their critical roles in the pathogenic mechanisms of the respective organisms—such as viral entry, replication, immune evasion, and bacterial adhesion. The three-dimensional crystal structures of these proteins were retrieved from the RCSB Protein Data Bank (PDB) using the respective PDB IDs: 2VIU (HA), 1NNB (Neuraminidase), 7F2B (N protein), 1HRI (VP1), 6BNC (Phosphoethanolamine transferase), 4MR0 (PfbA), 5XYA (Chemokine protease C), and 2OTO (M protein). All structures selected were of the lowest resolution available, which is beneficial for achieving higher quality in structural detail. The structures were resolved using X-ray diffraction techniques, ensuring precise modeling of ligand-protein interactions during the molecular docking simulations. These selected targets form the molecular basis for evaluating the binding affinity and inhibitory potential of the active compounds in the Kadhaayu formulation.

EXAMPLE 2: Method of Preparation
Raw materials are procured from certified botanical suppliers. Each herb undergoes testing for foreign matter, heavy metals, pesticide residues, and microbial contamination. The authenticated herbs are then washed thoroughly in clean water to remove soil and debris. Shade drying is carried out for thermolabile constituents, while oven drying at 40–50 °C is used for robust plant parts such as bark and seeds.

The dried herbs are pulverized into coarse powder of 40–60 mesh size, with volatile-rich herbs such as clove and nutmeg powdered immediately before extraction to minimize loss of essential oils. Extraction is carried out based on the plant part: roots and rhizomes (Ashwagandha, Ginger, Mulethi, Echinacea, Turmeric) undergo hydro-alcoholic extraction (70:30 ethanol-water) by Soxhlet for 6–8 hours; leaves (Tulsi, Green Tea, Adulsa, Brahmi) are processed by aqueous infusion at 80 °C for 2 hours; barks and seeds (Cinnamon, Coriander, Nutmeg) are extracted by hydro-ethanolic percolation; resin (Asafoetida) is directly powdered without extraction; and fruits (Amla, Black Pepper) are subjected to cold maceration for 24 hours to preserve phenolics and vitamin C. The resulting extracts are filtered through muslin cloth and Whatman filter paper, followed by concentration under reduced pressure at 45 °C using a rotary evaporator.

The concentrated extracts are dried using spray-drying to produce free-flowing powders, ensuring moisture content is maintained below 5% to prevent microbial growth. All dried extracts are then uniformly blended in a stainless-steel double-cone blender, with homogeneity confirmed through random sampling and TLC fingerprinting. The final blend is packed as a Kadha base powder for decoction use in moisture-proof containers and stored at 25 °C with a relative humidity of not more than 40%.

The extract blend can be formulated into different dosage forms such as tablets, capsules, and decoction. For tablets, the blend is granulated with microcrystalline cellulose, starch, and a natural binder like acacia gum, compressed into 500 mg units, and coated for stability. In capsule form, the dried extracts are filled into vegetarian HPMC capsules at 500 mg per capsule, offering better patient compliance and portability. As a traditional decoction (Kadha), 5 g of the powder is boiled in 150 mL of water until the volume reduces to 50 mL, with a recommended dosage of one cup twice daily.

EXAMPLE 3: In silico pharmacokinetic studies
In silico pharmacokinetic studies were conducted to evaluate the absorption, distribution, metabolism, and excretion (ADME) profiles of the phytocompounds present in the Kadhaayu formulation using the pkCSM and SwissADME platforms. Parameters assessed included human intestinal absorption (HIA), blood-brain barrier (BBB) permeability, skin permeation (logKp), and interaction with permeability glycoprotein (P-gp). Most compounds demonstrated good HIA, except for Glycyrrhizin, Chicoric acid, and Bacopaside A, which showed poor absorption, while Vitamin C exhibited average absorption at 39.154%. Only eight compounds—Cinnamaldehyde, Piperine, 6-gingerol, Linalool, Eugenol, Myristicin, Sabinene, and Ferulic acid—showed potential for BBB penetration. Several compounds, including Withaferin A, Emblicanin A and B, Catechin, Convolvidine, Glycyrrhizin, Vasicine, Chicoric acid, and Bacopaside A, were identified as non-substrates for P-gp, which is crucial for determining drug efflux and bioavailability. Metabolic profiling indicated that most compounds were non-inhibitors of key cytochrome P450 enzymes, with few exceptions: Piperine, 6-gingerol, Eugenol, and Myristicin inhibited CYP1A2; Piperine inhibited CYP2C19; Curcumin, Piperine, and α-mangostin inhibited CYP2C9; while Curcumin was the only compound to inhibit CYP3A4. All compounds were non-inhibitors of CYP2D6. Regarding skin permeability, most compounds had low transdermal penetration (logKp > –2.5), except for Cinnamaldehyde, Linalool, Eugenol, Myristicin, and Sabinene, which showed relatively higher permeability.

Table 4. Pharmacokinetic properties of the phytoligands.
SI. No. Ligands Human-intestinal absorption Blood-brain permeant P-glycoprotein substrate CYP450 1A2 inhibitor CYP450 2C19 inhibitor CYP450 2C9 inhibitor CYP450 2D6 inhibitor CYP450 3A4 inhibitor Skin permeation as log Kp
1 Withaferin A 84.481 % No Yes No No No No No -3.256
2 Curcumin 82.19 % No No No No Yes No Yes -2.764
3 Cinnamaldehyde 95.015 % Yes No No No No No No -2.355
4 Emblicanin A 69.128 % No Yes No No No No No -2.735
5 Emblicanin B 100 % No Yes No No No No No -2.735
6 Catechin 68.829 % No Yes No No No No No -2.735
7 Piperine 94.444 % Yes No Yes Yes Yes No No -3.131
8 6-gingerol 92.416 % Yes No Yes No No No No -2.817
9 Convolvidine 100 % No Yes No No No No No -2.768
10 Linalool 93.163 % Yes No No No No No No -1.737
11 Eugenol 92.041 % Yes No Yes No No No No -2.207
12 Myristicin 96.255 % Yes No Yes No No No No -2.373
13 Sabinene 95.356 % Yes No No No No No No -1.342
14 Glycyrrhizin 0 % No Yes No No No No No -2.735
15 Vasicine 86.22 % No Yes No No No No No -2.827
16 Chicoric acid 8.17 % No Yes No No No No No -2.735
17 Bacopaside A 2.703 % No Yes No No No No No -2.735
18 Vitamin C 39.154 % No No No No No No No -2.955
19 Ferulic acid 93.685 % Yes No No No No No No -2.72
20 α-mangostin 93.647 % No No No No Yes No No -2.736

Toxicity prediction of the phytocompounds in the Kadhaayu formulation was conducted based on six key parameters: hepatotoxicity, carcinogenicity, immunotoxicity, mutagenicity, cytotoxicity, and acute oral toxicity. Compounds like Emblicanin A and B, Catechin, Linalool, Eugenol, Sabinene, Vasicine, Bacopaside A, and Vitamin C showed no toxicity. Withaferin A exhibited both immunotoxic and cytotoxic effects, while compounds such as Curcumin, Piperine, 6-gingerol, Myristicin, Glycyrrhizin, Chicoric acid, Ferulic acid, and α-mangostin were immunotoxic; notably, Piperine and Myristicin were also found to be carcinogenic. Cinnamaldehyde showed mutagenic potential, and Convolvidine was identified as carcinogenic. Acute toxicity (LD₅₀) classification using the ProTox-II tool indicated most compounds fall within safe toxicity classes as per the GHS standards, supporting the formulation’s overall safety profile.
Table 5: Toxicity Prediction of Ligands
S. No. Ligands Hepatotoxicity Carcinogenicity Immunotoxicity Mutagenicity Cytotoxicity Acute toxicity
1 Withaferin A Inactive Inactive Active Inactive Active 300 mg/kg
Class: 3
2 Curcumin Inactive Inactive Active Inactive Inactive 2000 mg/kg
Class: 4
3 Cinnamaldehyde Inactive Inactive Inactive Active Inactive 1850 mg/kg
Class: 4
4 Emblicanin A Inactive Inactive Inactive Inactive Inactive 10000 mg/kg
Class: 6
5 Emblicanin B Inactive Inactive Inactive Inactive Inactive 1213 mg/kg
Class: 4
6 Catechin Inactive Inactive Inactive Inactive Inactive 10000 mg/kg
Class: 6
7 Piperine Inactive Active Active Inactive Inactive 330 mg/kg
Class: 4
8 6-gingerol Inactive Inactive Active Inactive Inactive 250 mg/kg
Class: 3
9 Convolvidine Inactive Active Inactive Inactive Active 650 mg/kg
Class: 4
10 Linalool Inactive Inactive Inactive Inactive Inactive 2200 mg/kg
Class: 5
11 Eugenol Inactive Inactive Inactive Inactive Inactive 1930 mg/kg
Class: 4
12 Myristicin Inactive Active Active Inactive Inactive 4260 mg/kg
Class: 5
13 Sabinene Inactive Inactive Inactive Inactive Inactive 5000 mg/kg
Class: 5
14 Glycyrrhizin Inactive Inactive Active Inactive Inactive 1750 mg/kg
Class: 4
15 Vasicine Inactive Inactive Inactive Inactive Inactive 290 mg/kg
Class: 3
16 Chicoric acid Inactive Inactive Active Inactive Inactive 5000 mg/kg
Class: 5
17 Bacopaside A Inactive Inactive Inactive Inactive Inactive 4000 mg/kg
Class: 5
18 Vitamin C Inactive Inactive Inactive Inactive Inactive 3367 mg/kg
Class: 5
19 Ferulic acid Inactive Inactive Active Inactive Inactive 1772 mg/kg
Class: 4
20 α-mangostin Inactive Inactive Active Inactive Inactive 1500 mg/kg
Class: 4

EXAMPLE 4: Antioxidant Potential
To evaluate antioxidant activity, the Kadhaayu formulation was subjected to the DPPH radical scavenging assay. A measured concentration of 200 µg/mL of the extract was incubated with a DPPH solution, and the decrease in absorbance was recorded at 517 nm. The formulation showed 82% radical scavenging, surpassing the values typically observed for individual herbal extracts (55–65%). In another test, the FRAP assay was performed by incubating the extract with ferric-tripyridyltriazine reagent, and absorbance was measured at 593 nm. Kadhaayu displayed a ferric reducing capacity equivalent to 635 µM Fe²⁺ per gram extract. Additionally, the ABTS radical cation assay was conducted by reacting the extract with pre-formed ABTS⁺ radicals, and inhibition was recorded spectrophotometrically. At 150 µg/mL, the formulation inhibited 78% of radicals, highlighting its strong antioxidant potential. Results of antioxidant activity of prepared formulation were shown in table 6.

EXAMPLE 5: Antimicrobial Studies
The antimicrobial activity of Kadhaayu was assessed by the disc diffusion method. Sterile discs were impregnated with 100 µg/mL of the extract and placed on agar plates inoculated with test organisms. After incubation, zones of inhibition were measured around the discs. The extract produced a 20 mm inhibition zone against Escherichia coli, a 22 mm zone against Staphylococcus aureus, and an 18 mm zone against Candida albicans. These results demonstrate that Kadhaayu exhibits broad-spectrum antimicrobial activity, effective against both bacterial and fungal pathogens. Results of anti-microbial activity of prepared formulation were shown in table 6.

EXAMPLE 6: Anti-inflammatory Evaluation
Anti-inflammatory activity was tested using the protein denaturation assay. A solution of bovine serum albumin was incubated with the extract at a concentration of 300 µg/mL, followed by heat treatment. The degree of protein denaturation was monitored spectrophotometrically, and Kadhaayu showed 75% inhibition of denaturation, comparable to the standard drug diclofenac (78%). In the membrane stabilization assay, erythrocyte suspensions were exposed to hypotonic saline along with the extract (250 µg/mL). The extent of hemolysis was measured, and the extract inhibited lysis by 72%, confirming its membrane-protective and anti-inflammatory activity. Results of anti-inflammatory activity of prepared formulation were shown in table 6.

EXAMPLE 7: Immunomodulatory Studies
The immunomodulatory effect of Kadhaayu was demonstrated using macrophage cell lines. In the MTT cell viability assay, macrophages were treated with the extract at 150 µg/mL, and cell proliferation was quantified by measuring formazan formation at 570 nm. The formulation enhanced macrophage proliferation by 38%, indicating immune activation. In the nitric oxide release assay, macrophages incubated with the extract produced significantly higher NO levels, measured using the Griess reagent. This confirmed that Kadhaayu stimulates macrophage activity and enhances immune response mechanisms. Results of immunomodulatory activity of prepared formulation were shown in table 6.
Table 6: Various Activity Results of Prepared Kadhayu Formulation.
Assay / Organism Metric Result (Kadhaayu)
DPPH % inhibition @200 µg/mL 82
FRAP µM Fe²⁺ eq./g 635
ABTS % inhibition @150 µg/mL 78
E. coli (disc diffusion) Zone (mm) @100 µg/mL 20
S. aureus (disc diffusion) Zone (mm) @100 µg/mL 22
C. albicans (disc diffusion) Zone (mm) @100 µg/mL 18
Protein Denaturation % inhibition @300 µg/mL 75
Membrane Stabilization % hemolysis inhibition @250 µg/mL 72
MTT (macrophages) % proliferation @150 µg/mL 38

EXAMPLE 8: Syngerstic Activity
To evaluate the synergistic effects of the herbal formulation Kadhaayu, different in-vitro assays were performed. The antioxidant potential was assessed using DPPH radical scavenging assay (at 200 µg/mL) and ABTS radical scavenging assay (at 150 µg/mL). Antimicrobial activity was determined by measuring the zone of inhibition (mm) against E. coli and S. aureus at 100 µg/mL. The anti-inflammatory potential was measured through protein denaturation inhibition assay at 300 µg/mL. Finally, the immunomodulatory activity was assessed by the MTT proliferation assay at 150 µg/mL, which indicates macrophage proliferation.

Endpoint Best Individual (% / mm) Kadhaayu Combined (% / mm)
DPPH inhibition @200 µg/mL 65 82
ABTS inhibition @150 µg/mL 62 78
E. coli zone (mm) @100 µg/mL 16 20
S. aureus zone (mm) @100 µg/mL 17 22
Protein denaturation inhibition @300 µg/mL 40 75
MTT proliferation @150 µg/mL 25 38
The comparative analysis between individual herbal extracts and the combined formulation (Kadhaayu) demonstrated a significant synergistic effect across all tested parameters. Antioxidant activity was markedly enhanced, with Kadhaayu showing 82% DPPH inhibition and 78% ABTS inhibition, outperforming the best individual extracts (65% and 62%, respectively).

In antimicrobial assays, Kadhaayu exhibited a 20 mm inhibition zone against E. coli and 22 mm against S. aureus, both higher than the best individual activities (16 mm and 17 mm, respectively).

For anti-inflammatory activity, Kadhaayu achieved 75% inhibition of protein denaturation, nearly doubling the effect of the best individual extract (40%).
Immunomodulatory activity was also enhanced, with Kadhaayu increasing macrophage proliferation by 38%, compared to only 25% with individual extracts.

While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other changes in the preferred embodiment of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.
, Claims:We Claim,
1. A herbal Kadhaayu composition comprising
a) Withania somnifera (Ashwagandha) root extract in an amount of 100 to 120 mg;
b) Curcuma longa (Turmeric) rhizome extract in an amount of 100 to 150 mg;
c) Cinnamomum zeylanicum (Cinnamon) bark extract in an amount of 50 to 80 mg;
d) Garcinia mangostana (Mangosteen) pericarp extract in an amount of 100 to 180 mg;
e) Camellia sinensis (Green Tea) leaf extract in an amount of 50 to 100 mg;
f) Piper nigrum (Black Pepper) fruit extract in an amount of 25 to 50 mg;
g) Zingiber officinale (Ginger) rhizome extract in an amount of 50 to 80 mg;
h) Ocimum sanctum (Tulsi) leaf extract in an amount of 50 to 80 mg;
i) Convolvulus prostratus (Shankpushpi) whole plant extract in an amount of 50 to 80 mg;
j) Coriandrum sativum (Coriander) seed extract in an amount of 50 to 70 mg;
k) Syzygium aromaticum (Clove) bud extract in an amount of 25 to 35 mg;
l) Myristica fragrans (Nutmeg) seed extract in an amount of 25 to 35 mg;
m) Glycyrrhiza glabra (Mulethi) root extract in an amount of 50 to 60 mg;
n) Adhatoda vasica (Adulsa) leaf extract in an amount of 50 to 70 mg;
o) Echinacea purpurea (Echinacea) root extract in an amount of 50 to 60 mg;
p) Bacopa monnieri (Brahmi) whole plant extract in an amount of 50 to 60 mg;
q) Ferula asafoetida (Asafoetida) resin in an amount of 25 to 30 mg; and
r) Emblica officinalis (Amla) fruit extract in an amount of 100 to 150 mg.
2. The herbal Kadhaayu composition, as claimed in claim 1, wherein the method of preparing a nutraceutical composition comprising the steps of:
h) testing said materials for foreign matter, heavy metals, pesticide residues, and microbial contamination;
i) washing and drying the said herbs under conditions selected from shade drying for thermolabile constituents and oven drying at 40–50 °C for robust plant parts;
j) pulverizing the dried herbs into coarse powder of 40–60 mesh size;
k) subjecting the powdered herbs to extraction processes selected from (i) hydro-alcoholic extraction of roots and rhizomes by Soxhlet, (ii) aqueous infusion of leaves at 80 °C, (iii) hydro-ethanolic percolation of barks and seeds, (iv) direct pulverization of resins, and (v) cold maceration of fruits;
l) filtering the resulting extracts; concentrating the filtrates under reduced pressure at about 45 °C;
m) drying the concentrated extracts by spray drying to obtain free-flowing powders having a moisture content below 5%;
n) blending the dried extracts uniformly in a stainless-steel blender;
o) confirming homogeneity by thin layer chromatography fingerprinting; and packing the final blend as a Kadha base powder in moisture-proof containers for storage at a temperature of about 25 °C and relative humidity of not more than 40%.
3. The herbal Kadhaayu composition as claimed in claim 1, wherein the extract blend is formulated into a dosage form selected from (i) tablets, wherein the blend is granulated with microcrystalline cellulose, starch, and a natural binder such as acacia gum, compressed into about 500 mg units and optionally coated for stability; (ii) capsules, wherein the dried extracts are filled into vegetarian hydroxypropyl methylcellulose (HPMC) capsules at about 500 mg per capsule for improved patient compliance and portability; or (iii) a decoction (Kadha), wherein about 5 g of the powder is boiled in about 150 mL of water until the volume reduces to about 50 mL, with a recommended dosage of one cup administered twice daily.
4. The herbal Kadhaayu composition as claimed in claim 1, wherein the formulation exhibits (i) DPPH radical inhibition of about 82% at 200 µg/mL; (ii) ABTS radical inhibition of about 78% at 150 µg/mL; (iii) antibacterial activity against E. coli with a zone of inhibition of about 20 mm at 100 µg/mL; (iv) antibacterial activity against S. aureus with a zone of inhibition of about 22 mm at 100 µg/mL; (v) protein denaturation inhibition of about 75% at 300 µg/mL; and (vi) MTT proliferation inhibition of about 38% at 150 µg/mL.
5. The herbal Kadhaayu composition as claimed in claim 1, wherein the composition is effective against pathogens selected from Influenza A, SARS-CoV-2, Human rhinovirus, Moraxella catarrhalis, Streptococcus pneumoniae, and Streptococcus pyogenes.
6. The herbal Kadhaayu composition as claimed in claim 1, wherein the delivery form is selected from decoction, syrup, capsule, tablet, or instant tea.
7. The herbal Kadhaayu composition as claimed in claim 1, which exhibits binding affinity scores in the range of –4.2 to –10.3 kcal/mol against target proteins as determined by molecular docking.
Dated this 30 August 2025

Dr. Amrish Chandra
Agent of the applicant
IN/PA No: 2959