Abstract: SUGAR FREE NOVEL NATURAL FOOD SUPPLEMENT FOR DAILY HEALTH SUPPLEMENT AND IMMUNITY SUPPORT ABSTRACT The present invention relates to a novel polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual. The novel sugar free composition comprises of powdered admixture of fruit pulp aqueous extract of Emblica officinalis, green fruit extract of Artocarpus heterophyllus, dried roots extract of Glycyrrhiza glabra, fruit pulp extract of Phoenix dactylifera; a ‘powdered blend of 34 other plant extracts’; a zero-calorie natural sweetener; a clarified butter; a cold press oil from seeds of Schistosoma indicum; a pharmaceutically acceptable excipient; and a powdered admixture of one or more herbal base additives. The said polyherbal sugar free composition is also used as a food supplement for boosting immunity in an individual without causing any side effects as it comprises various naturals’ extracts. The present invention further relates to a method of synthesizing the same. FIG. 1 Dated this 09th day of February, 2023 For, SARVOTHAM CARE LIMITED BY THEIR AGENT (DR. BABITHA THARAPPAN) IN/PA-1614 ATV-LEGAL
DESC:
FORM 2
The Patents Act 1970
(39 of 1970)
&
The Patent Rules 2003
COMPLETE SPECIFICATION
(See Section 10 and rule 13)
TITLE OF THE INVENTION:
SUGAR FREE NOVEL NATURAL FOOD SUPPLEMENT FOR DAILY HEALTH SUPPLEMENT AND IMMUNITY SUPPORT
APPLICANT:
Name: SARVOTHAM CARE LIMITED
Nationality: Indian
Address: #1-20-248, 1st Floor, Umajay Complex, Rasoolpura,
Secunderabad, Telengana, India - 500003
PREAMBLE OF THE DESCRIPTION:
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED
A) TECHNICAL FIELD OF INVENTION
[001] The present invention generally relates to a polyherbal composition, in particular to a sugar free natural composition. The present invention more particularly relates to a novel polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual. The present invention further relates to a method of synthesizing the same.
B) BACKGROUND OF INVENTION
[002] The metabolic syndrome (MetS) is a major and escalating public-health and clinical challenge worldwide in the wake of urbanization, surplus energy intake, increasing obesity, and sedentary life habits. Metabolic syndrome is (MetS) is a cluster of metabolic abnormalities defined by a constellation of interconnected physiological, biochemical, clinical, and metabolic factors that directly increases the risk of cardiovascular disease, type 2 diabetes mellitus (T2DM), and causes mortality. Insulin resistance, hypertension, visceral adiposity, atherogenic dyslipidaemia, endothelial dysfunction, genetic susceptibility, elevated blood pressure, hypercoagulable state, and chronic stress are the several factors which constitute the syndrome. MetS is strongly associated with an increased risk of developing atherosclerotic cardiovascular disease (CVD).
[003] MetS is rapidly increasing in prevalence worldwide as a consequence of the continued obesity “epidemic”, and as a result will have a considerable impact on the global incidence of cardiovascular disease and type 2 diabetes. Prevalence of metabolic syndrome varies among different populations depending on gender, age, and ethnicity. The prevalence of the metabolic syndrome ranges from 20 to 25% in the adult population and 0 to 19.2% in children; but it can reach almost 80% in type 2 diabetes patients. The prevalence of obesity and metabolic syndrome is rapidly increasing in India and other South Asian countries, leading to increased mortality and morbidity due to cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM).
[004] The metabolic syndrome (MetS) is also called as syndrome X, insulin resistance syndrome, Reaven syndrome, and “the deadly quartet”. The main drivers for metabolic syndrome (MetS) are related to rapid nutritional changes, lifestyle and socioeconomic transitions, consequent to increasing affluence, urbanization, mechanization, and rural-to-urban migration.
[005] MetS is a state of chronic low-grade inflammation as a consequence of complex interplay between genetic and environmental factors. The pathogenic mechanisms of MetS are complex and remain to be fully elucidated. Whether the individual components of MetS represent distinct pathologies or manifestations of a common pathogenic mechanism is still debated. The wide variation in geographic distribution of MetS and the recent ‘catch up’ in the developing world emphasize the importance of environmental and lifestyle factors such as the consumption of excess calories and lack of physical activity as being major contributors. Visceral adiposity has been demonstrated to be a primary trigger for most of the pathways involved in MetS, thus stressing the importance of a high caloric intake as a major causative factor. Of all the proposed mechanisms, insulin resistance, neurohormonal activation, and chronic inflammation appear to be the main players in the initiation, progression, and transition of MetS to CVD.
[006] Chronic inflammation is known to be associated with visceral obesity and insulin resistance which is characterized by production of abnormal adipocytokines such as tumour necrosis factor a, interleukin-1 (IL-1), IL-6, leptin, and adiponectin. The interaction between components of the clinical phenotype of the syndrome with its biological phenotype (insulin resistance, dyslipidaemia, etc.) contributes to the development of a proinflammatory state and further a chronic, subclinical vascular inflammation which modulates and results in atherosclerotic processes. Lifestyle modification remains the initial intervention of choice for such population. Modern lifestyle modification therapy combines specific recommendations on diet and exercise with behavioural strategies.
[007] Clinical identification and management of patients with the MetS are important to begin efforts to adequately implement the treatments to reduce their risk of subsequent diseases. A first-line therapeutic approach for metabolic diseases includes lifestyle changes, primarily weight loss, diet, and exercise. Nonetheless, often these lifestyle modifications are insufficient to normalize risk factors in patients, and treatment requires multi-drug therapy.
[008] Polypharmacy for metabolic diseases includes lipid lowering agents, anti-hypertensive agents, anti-diabetic agents, heart failure drugs, and anti-obesity therapies. Reduction of low-density lipoprotein (LDL) cholesterol by statins is a common treatment for patients with metabolic diseases. Angiotensin system inhibitors are commonly used to combat hypertension associated with metabolic diseases. Heart failure in metabolic disease is treated with diuretics, beta-adrenergic blockers, or calcium channel blockers. Anti-diabetic agents include peroxisome proliferator-activated receptor-? (PPAR?) agonist insulin sensitizing agents, glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP4) inhibitors, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Obesity can be treated with gastrointestinal lipase inhibitors, central nervous system acting drugs like serotonin 2C receptor agonists, or by bariatric surgery. A primary therapeutic approach for metabolic diseases has been to identify and treat each symptom or condition separately. This approach leads to several drugs being prescribed to patients with metabolic diseases.
[009] A multi-drug regimen or polypharmacy is a major problem for the treatment of patients with metabolic diseases due to poor patient compliance, side effects, and drug-drug interactions. Alternatively, ayurvedic interventions are also known in treating various metabolic syndromes. Many herbal formulations have been developed based on the knowledge of the healing properties of various herbs.
[0010] WIPO Patent Application No. WO2018211527A1 discloses herbal formulation for treatment and management of Metabolic disorders and associated complications comprising atleast one herb selected from a group consisting of Emblica officinalis, Terminalia bellerica, Terminalia chubula, Zingiber officinalis, Piper longum, Piper nigrum, Embeliaribes, Curcuma longa, Terminalia arjuna, Sidarhom bifolia, Withania somnifera, Inula racemose, Punica grnatum, Nardostachysjatamansi, Boerhaviadiffusa, Picrorhizakurroa, Ocimum sanctum, Azadirachta indica, Aristolochia indica, Aegle marmelos, Cyperus rotundas, Hemidesmus indicus, Trichosanthus dioica, Sanatalum album, Glycerrhiza glabra, Woodfordiafruiticosa, Mucuna pruriens, Myrica nagi, Syzygiumcumini, Tinospora cordifolia and Bamboo manna, or their extracts thereof.
[0011] Indian Patent Application 202111000554 discloses oral sugar free solid composition consisting essentially of Piper longum Linn., Zingiber officinale Roxb., Tinospora cordifolia Willd., Ficus hispida Linn., Inula racemosa Hook., Woodfordiafruticosa Kurz., Vitis vinifera Linn. and one or more pharmaceutically acceptable excipients for prevention and treatment of respiratory disorders.
[0012] The compositions disclosed in prior art are useful for treatment of one or more metabolic syndrome or disorders, but they do not boost immunity of a patient. Also, the ayurvedic formulations generally available in market contains sugar. When these drugs are taken by diabetic patients, it may lead to increase in sugar levels.
[0013] Various attempts have been made to prepare formulations for treatment of metabolic syndrome or disorders especially, still there is a need for a balanced formulation especially for use in diabetic patients which not only prevents and treats metabolic syndrome but at the same time should be suitable for consumption by diabetic patients without fear of increasing blood sugar levels and should boost the immunity of a person taking it. The formulation should be useful both as preventive medication as well as for therapeutic treatment of the metabolic syndrome and should be suitable for diabetic patients. Hence, there is a need to develop a formulation or composition comprising of plant or herbal extracts which provides above properties without causing any side effects.
[0014] The value additions and above-mentioned shortcomings, disadvantages and problems are addressed herein, as detailed below.
C) OBJECT OF INVENTION
[0015] An object of the present invention provides a novel poly herbal sugar free composition for treating metabolic syndrome and boosting immunity in an individual.
[0016] Another object of the present invention is to provide a polyherbal sugar free composition which is absolutely free from synthetic chemicals, added sugar, honey, added starch, and artificial sweeteners.
[0017] Yet another object of the present invention is to provide a polyherbal sugar free composition which possesses secondary metabolites including polyphenols, tannins, & flavonoids; and natural nutrients including vitamins, amino acids, fatty acids & minerals that helps as health and immune supplement in boosting immunity in an individual.
[0018] Yet another object of the present invention is to provide a polyherbal sugar free composition which is low caloric composition, diabetic friendly and good palatability.
[0019] Yet another object of the present invention is to provide a method of synthesizing a novel polyherbal sugar free composition for treating metabolic syndrome and boosting immunity in an individual.
[0020] These and other objects and advantages of the embodiments herein will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.
D) SUMMARY OF INVENTION
[0021] The various embodiments of the present invention provide a novel polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual. The poly herbal sugar free composition comprises a powdered admixture of fruit pulp aqueous extract of Emblica officinalis, green fruit extract of Artocarpus heterophyllus, dried roots extract of Glycyrrhiza glabra and fruit pulp extract of Phoenix dactylifera, a powdered blend of 34 other plant extracts, a zero-calorie natural sweetener, a clarified butter, a cold press oil from seeds of Schistosoma indicum, a pharmaceutically acceptable excipient, and one or more herbal base additives.
[0022] According to an embodiment of the present invention, the powdered blend of 34 other plant extracts comprises a stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera.
[0023] According to an embodiment of the present invention, the herbal base additives are fruit extract of Piper longum, stamen extract of Mesua ferrea, fruit extract of Elettaria cardamomum, leaf extract of Cinnamomum tamala, stem bark extract of Cinnamomum verum, and a silicate extract of Bamboo manna.
[0024] According to an embodiment of the present invention, the fruit pulp aqueous extract of Emblica officinalis is present in an amount of 63.5% (w/w).
[0025] According to an embodiment of the present invention, the green fruit extract of Artocarpus heterophyllus is present in an amount of 2.0% (w/w).
[0026] According to an embodiment of the present invention, the dried roots extract of Glycyrrhiza glabra is present in an amount of 4.0% (w/w).
[0027] According to an embodiment of the present invention, the fruit pulp extract of Phoenix dactylifera is present in an amount of 22.14% (w/w).
[0028] According to an embodiment of the present invention, the stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera is present in an amount of 50 grams each.
[0029] According to an embodiment of the present invention, the zero-calorie natural sweetener is steviol.
[0030] According to an embodiment of the present invention, the said zero-calorie natural sweetener is present in the amount of 0.20% (w/w).
[0031] According to an embodiment of the present invention, the clarified butter is present in the amount of 2.0% (w/w).
[0032] According to an embodiment of the present invention, the cold press oil from seeds of Schistosoma indicum is present in the amount of 2.0% (w/w).
[0033] According to an embodiment of the present invention, the pharmaceutically acceptable excipient is citric acid.
[0034] According to an embodiment of the present invention, the pharmaceutically acceptable excipient is present in the amount of 0.75% (w/w).
[0035] According to an embodiment of the present invention, the fruit extract of Piper longum, the stamen extract of Mesua ferrea, the fruit extract of Elettaria cardamomum, the leaf extract of Cinnamomum tamala, and the stem bark extract of Cinnamomum verum is present in the amount of 10 grams each.
[0036] According to an embodiment of the present invention, the silicate extract of Bamboo manna is present in the amount of 100 grams.
[0037] According to another embodiment of the present invention, a method of synthesizing a polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual is provided. The method comprises: a) preparing an aqueous extract of fruit pulp of Emblica officinalis by dissolving the graded fruit pulp of Emblica officinalis in water; b) preparing a dried powdered admixture by blending a green fruit extract of Artocarpus heterophyllus, dried roots extract of Glycyrrhiza glabra, fruit pulp extract of Phoenix dactylifera with the aqueous extract of fruit pulp of Emblica officinalis of step (a); c) preparing an aqueous extract of ‘powdered blend of 34 other plant extracts’; d) preparing a dried powdered admixture of one or more herbal base additives; e) blending the dried powdered admixture of step (b), the aqueous extract of powdered blend of 34 other plant extracts of step (c), the dried powdered admixture of one or more herbal base additives of step (d), a zero-calorie natural sweetener, and a pharmaceutically acceptable excipient with a clarified butter and a cold press oil from seeds of Schistosoma indicum to obtain a mixture; and f) heating the mixture at 80 to 90oC under continuous stirring and cooled to obtain final product.
[0038] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.
E) BRIEF DESCRIPTION OF DRAWINGS
[0039] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:
[0040] FIG. 1 is a schematic representation showing the steps involved in the preparation of a polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity, according to an embodiment of the present invention.
[0041] FIG. 2A shows graphical representation of the percentage inhibition of DPPH by the ascorbic acid (standard) in a concentration dependent manner, according to an embodiment of the present invention.
[0042] FIG. 2B shows graphical representation of the percentage inhibition of DPPH by the prepared polyherbal sugar free food supplement (test substance) in a concentration dependent manner, according to an embodiment of the present invention.
[0043] FIG. 3A shows graphical representation of the percentage inhibition of nitric oxide by the ascorbic acid (standard) in a concentration dependent manner, according to an embodiment of the present invention.
[0044] FIG. 3B shows graphical representation of the percentage inhibition of nitric oxide by the prepared polyherbal sugar free food supplement (test substance) in a concentration dependent manner, according to an embodiment of the present invention.
F) DETAILED DESCRIPTION OF DRAWINGS
[0045] In the following detailed description, a reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. The embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical, electronic, and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.
[0046] According to an embodiment of the present invention, a novel polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual is provided. The poly herbal sugar free composition comprises a powdered admixture of fruit pulp aqueous extract of Emblica officinalis, green fruit extract of Artocarpus heterophyllus, dried roots extract of Glycyrrhiza glabra and fruit pulp extract of Phoenix dactylifera; a powdered blend of 34 other plant extracts, a zero-calorie natural sweetener; a clarified butter; a cold press oil from seeds of Schistosoma indicum; a pharmaceutically acceptable excipient; and one or more herbal base additives.
[0047] According to an embodiment of the present invention, the fruit pulp aqueous extract of Emblica officinalis is present in an amount of 63.5% (w/w).
[0048] According to an embodiment of the present invention, the green fruit extract of Artocarpus heterophyllus is present in an amount of 2.0% (w/w).
[0049] According to an embodiment of the present invention, the dried roots extract of Glycyrrhiza glabra is present in an amount of 4.0% (w/w).
[0050] According to an embodiment of the present invention, the fruit pulp extract of Phoenix dactylifera is present in an amount of 22.14% (w/w).
[0051] According to an embodiment of the present invention, the said powdered blend of 34 other plant extracts comprises a stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera.
[0052] According to an embodiment of the present invention, the stem or bark extract of Aegle marmelos is present in an amount of 50 grams.
[0053] According to an embodiment of the present invention, the stem or bark extract of Clerodendrum phlomidis is present in an amount of 50 grams.
[0054] According to an embodiment of the present invention, the stem or bark extract of Gmelina arborea is present in an amount of 50 grams.
[0055] According to an embodiment of the present invention, the stem or bark extract of Oroxylum indicum is present in an amount of 50 grams.
[0056] According to an embodiment of the present invention, the stem or bark extract of Stereospermum suaveolens is present in an amount of 50 grams.
[0057] According to an embodiment of the present invention, the fruit extract of Tribulus terrestris is present in an amount of 50 grams.
[0058] According to an embodiment of the present invention, the whole plant part extract of Desmodium gangeticum is present in an amount of 50 grams.
[0059] According to an embodiment of the present invention, the whole plant part extract of Solanum indicum is present in an amount of 50 grams.
[0060] According to an embodiment of the present invention, the whole plant part extract of Solanum surattense is present in an amount of 50 grams.
[0061] According to an embodiment of the present invention, the gall extract of Pistacia integerrima is present in an amount of 50 grams.
[0062] According to an embodiment of the present invention, the fruit extract of Vitis vinifera is present in an amount of 50 grams.
[0063] According to an embodiment of the present invention, the pericarp extract of Terminalia chebula is present in an amount of 50 grams.
[0064] According to an embodiment of the present invention, the stem extract of Tinospora cordifolia is present in an amount of 50 grams.
[0065] According to an embodiment of the present invention, the whole plant part extract of Sida cordifolia is present in an amount of 50 grams.
[0066] According to an embodiment of the present invention, the whole plant part extract of Phyllanthus niruri is present in an amount of 50 grams.
[0067] According to an embodiment of the present invention, the root extract of Justicia adhatoda is present in an amount of 50 grams.
[0068] According to an embodiment of the present invention, the root extract of Leptadenia reticulate is present in an amount of 50 grams.
[0069] According to an embodiment of the present invention, the rhizome extract of Curcuma zedoaria is present in an amount of 50 grams.
[0070] According to an embodiment of the present invention, the root extract of Inula racemose is present in an amount of 50 grams.
[0071] According to an embodiment of the present invention, the rhizome extract of Cyperus rotundus is present in an amount of 50 grams.
[0072] According to an embodiment of the present invention, the whole plant part extract of Phaseolus trilobus (Vigna trilobata) is present in an amount of 50 grams.
[0073] According to an embodiment of the present invention, the whole plant part extract of Termanus labialis is present in an amount of 50 grams.
[0074] According to an embodiment of the present invention, the whole plant part extract of Desmodium gangeticum is present in an amount of 50 grams.
[0075] According to an embodiment of the present invention, the whole plant part extract of Uraria picta is present in an amount of 50 grams.
[0076] According to an embodiment of the present invention, the fruit extract of Piper longum is present in an amount of 50 grams.
[0077] According to an embodiment of the present invention, the fruit extract of Martynia annua is present in an amount of 50 grams.
[0078] According to an embodiment of the present invention, the root tuber extract of Dioscorea bulbifera is present in an amount of 50 grams.
[0079] According to an embodiment of the present invention, the root tuber extract of Pueraria tuberosa is present in an amount of 50 grams.
[0080] According to an embodiment of the present invention, the whole plant part extract of Boerhavia diffusa is present in an amount of 50 grams.
[0081] According to an embodiment of the present invention, the flower extract of Nymphaea nouchali is present in an amount of 50 grams.
[0082] According to an embodiment of the present invention, the heartwood extract of Aquilaria agallocha is present in an amount of 50 grams.
[0083] According to an embodiment of the present invention, the heartwood extract of Santalum album is present in an amount of 50 grams.
[0084] According to an embodiment of the present invention, the root extract of Asparagus racemosus is present in an amount of 50 grams.
[0085] According to an embodiment of the present invention, the root extract of Withania somnifera is present in an amount of 50 grams.
[0086] According to an embodiment of the present invention, the said zero-calorie natural sweetener is steviol.
[0087] According to an embodiment of the present invention, the said zero-calorie natural sweetener is present in the amount of 0.20% (w/w).
[0088] According to an embodiment of the present invention, the clarified butter is present in the amount of 2.0% (w/w).
[0089] According to an embodiment of the present invention, the cold press oil from seeds of Schistosoma indicum is present in the amount of 2.0% (w/w).
[0090] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is citric acid.
[0091] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is present in the amount of 0.75% (w/w).
[0092] According to an embodiment of the present invention, the herbal base additives are fruit extract of Piper longum, stamen extract of Mesua ferrea, fruit extract of Elettaria cardamomum, leaf extract of Cinnamomum tamala, stem bark extract of Cinnamomum verum, and a silicate extract of Bamboo manna.
[0093] According to an embodiment of the present invention, the fruit extract of Piper longum is present in the amount of 10 grams.
[0094] According to an embodiment of the present invention, the stamen extract of Mesua ferrea is present in the amount of 10 grams.
[0095] According to an embodiment of the present invention, the fruit extract of Elettaria cardamomumis is present in the amount of 10 grams.
[0096] According to an embodiment of the present invention, the leaf extract of Cinnamomum tamalais is present in the amount of 10 grams.
[0097] According to an embodiment of the present invention, the stem bark extract of Cinnamomum verum is present in the amount of 10 grams.
[0098] According to an embodiment of the present invention, the silicate extract of Bamboo manna is present in the amount of 100 grams.
[0099] According to another embodiment of the present invention, a method of synthesizing a polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual is provided.
[00100] FIG. 1 is a schematic representation showing the steps involved in the preparation of a polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity, according to an embodiment of the present invention. With respect to FIG. 1, the method comprises: preparing an aqueous extract of fruit pulp of Emblica officinalis by dissolving the graded fruit pulp of Emblica officinalis in water (101); preparing a dried powdered admixture by blending a green fruit extract of Artocarpus heterophyllus, dried roots extract of Glycyrrhiza glabra, fruit pulp extract of Phoenix dactylifera with the aqueous extract of fruit pulp of Emblica officinalis (102); preparing an aqueous extract of ‘powdered blend of 34 other plant extracts’ (103); preparing a dried powdered admixture of one or more herbal base additives (104); blending the dried powdered admixture of step (102), the aqueous extract of powdered blend of 34 other plant extracts of step (103), the dried powdered admixture of one or more herbal base additives of step (104), a zero-calorie natural sweetener, and a pharmaceutically acceptable excipient with a clarified butter and a cold press oil from seeds of Schistosoma indicum to obtain a mixture (105); and heating the mixture at 80 to 90oC under continuous stirring and cooled to obtain final product (106).
[00101] According to an embodiment of the present invention, the fruits of Emblica officinalis are taken, cleaned and graded. The graded fruit pulp of Emblica officinalis is dissolved in water to obtain an aqueous extract of fruit pulp of Emblica officinalis.
[00102] According to an embodiment of the present invention, the ratio of the graded fruit pulp of Emblica officinalis to water is 1:8.
[00103] According to an embodiment of the present invention, the green fruits of Artocarpus heterophyllus are taken, cleaned and graded. The pericarp of the green fruits of Artocarpus heterophyllus is separated and made into pieces followed by subjecting to drying under shade. The dried pericarp is pulverized to obtain a pulverized coarse powder.
[00104] According to an embodiment of the present invention, the roots of Glycyrrhiza glabra are taken, cleaned and graded/crushed. The graded dried roots of Glycyrrhiza glabra are dried in sunlight to obtain a pulverized coarse powder.
[00105] According to an embodiment of the present invention, the fruits of Phoenix dactylifera are taken, cleaned and graded. The pericarp of the fruits of Phoenix dactylifera is separated and subjected to drying under shade. The dried pericarp is pulverized to obtain a pulverized coarse powder.
[00106] According to an embodiment of the present invention, the fruit pulp aqueous extract of Emblica officinalis is added in an amount of 63.5% (w/w).
[00107] According to an embodiment of the present invention, the green fruit extract of Artocarpus heterophyllus is added in an amount of 2.0% (w/w).
[00108] According to an embodiment of the present invention, the dried roots extract of Glycyrrhiza glabra is added in an amount of 4.0% (w/w).
[00109] According to an embodiment of the present invention, the fruit pulp extract of Phoenix dactylifera is added in an amount of 22.14% (w/w).
[00110] According to an embodiment of the present invention, the powdered blend of 34 other plant extracts is taken. The powdered blend of 34 other plant extracts is dissolved in water to obtain an aqueous extract of ‘powdered blend of 34 other plant extracts. The aqueous extract of the ‘powdered blend of 34 other plant extracts’ is spray dried.
[00111] According to an embodiment of the present invention, the ratio of the powdered blend of 34 other plant extracts to water is 1:10.
[00112] According to an embodiment of the present invention, the said powdered blend of 34 other plant extracts comprises stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera.
[00113] According to an embodiment of the present invention, the stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera is added in an amount of 50 grams each.
[00114] According to an embodiment of the present invention, one or more herbal base additives are taken.
[00115] According to an embodiment of the present invention, the said herbal base additives are fruit extract of Piper longum, stamen extract of Mesua ferrea, fruit extract of Elettaria cardamomum, leaf extract of Cinnamomum tamala, stem bark extract of Cinnamomum verum, and a silicate extract of Bamboo manna.
[00116] According to an embodiment of the present invention, the fruit extract of Piper longum, stamen extract of Mesua ferrea, fruit extract of Elettaria cardamomum, leaf extract of Cinnamomum tamala, and stem bark extract of Cinnamomum verum is added in an amount of 10 grams each.
[00117] According to an embodiment of the present invention, the silicate extract of Bamboo manna is added in an amount of 100 grams.
[00118] According to an embodiment of the present invention, the zero-calorie natural sweetener is taken.
[00119] According to an embodiment of the present invention, the said zero-calorie natural sweetener added is steviol.
[00120] According to an embodiment of the present invention, the said zero-calorie natural sweetener is added in the amount of 0.20% (w/w).
[00121] According to an embodiment of the present invention, the clarified butter is taken.
[00122] According to an embodiment of the present invention, the clarified butter is added in the amount of 2.0% (w/w).
[00123] According to an embodiment of the present invention, the cold press oil from seeds of Schistosoma indicum is taken.
[00124] According to an embodiment of the present invention, the cold press oil from seeds of Schistosoma indicum is added in the amount of 2.0% (w/w).
[00125] According to an embodiment of the present invention, the pharmaceutically acceptable excipient is taken.
[00126] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient added is citric acid.
[00127] According to an embodiment of the present invention, the said pharmaceutically acceptable excipient is added in the amount of 0.75% (w/w).
[00128] According to an embodiment of the present invention, an efficacy or anti-oxidant activity of prepared polyherbal sugar free food supplement is evaluated.
EXPERIMENTAL DETAILS
EVALUATION OF ANTI-OXIDANT ACTIVITY
[00129] BY DPPH ASSAY:
[00130] Preparation of test substance: 1mg of prepared polyherbal sugar free food supplement was dissolved separately in 1ml of DMSO to obtain the concentration of 1000µg/ml. Further the stock solution was serially diluted to obtain 1000 –62.5µg/ml to get the lower concentration.
[00131] Preparation of standard: 1mg of ascorbic acid was dissolved in 1ml of DMSO to obtain concentration of 1000µg/ml which was serially diluted to get lower conc. of 62.5, 125, 250, 500 and 1000µg/ml.
[00132] Preparation of 2, 2-Diphenly 1-picryl hydroxyl solution (DPPH, 100M): 22mg of DPPH was dissolved in 100 ml of methanol to get stock solution. From the stock solution, 18ml was taken and diluted to 100ml using methanol to obtain 100µM DPPH Solution.
[00133] DPPH Assay procedure: 96-well microtiter plates were taken and 0.01ml of different concentrations of test substance and standard was added separately in the test and test blank wells. 0.01ml of DMSO was taken as prepared polyherbal sugar free food supplement (test blank) and control blank. 0.2 ml of DPPH was added to the test and control whereas to the test blank and control blank 0.2ml of methanol was added in place of DPPH. Same procedure was repeated for standard by replacing the prepared polyherbal sugar free food supplement with standard. Test and control were performed in triplicates and test blank and control blank were conducted in singlet. The microtiter plate was incubated at 37°C for 30 minutes. Absorbance was measured at 490nm using microplate reader.
[00134] BY ABTS ASSAY:
[00135] Preparation of test substance: 1mg of prepared polyherbal sugar free food supplement was dissolved separately in 1ml of DMSO to obtain the concentration of 1000µg/ml. Further the stock solution was serially diluted to obtain 1000 –62.5µg/ml to get the lower concentration.
[00136] Preparation of standard: 1mg of ascorbic acid was dissolved in 1ml of DMSO to obtain concentration of 1000µg/ml which was serially diluted to get lower conc. of 62.5, 125, 250, 500 and 1000µg/ml.
[00137] Preparation of ABTS: In 5ml of distilled water, 5.48mg of ABTS was dissolved to get 2mM concentration and to this solution 17mM of 0.03ml potassium persulphate was added. The reaction mixture was left to stand at room temperature overnight in dark before use.
[00138] ABTS assay procedure: In test and test blank 0.2ml of different concentration of test substance was taken and 1.0 ml of PBS, 0.16 ml of ABTS solution was added to make a final volume of 1.36 ml. In control and control blank 0.2ml of methanol was taken in place of test substance. Instead of ABTS reagent, 0.16ml of distilled water was taken for test blank and control blank. All the tubes were incubated for 20 minutes. After incubation 0.1ml of reaction mixture was pipette out to microtiter plate. Absorbance was measured in ELISA reader at 734nm and values were recorded. Same procedure was repeated for standard by replacing test sample with standard. Test and control were performed in triplicate and test blank and control blank were conducted in singlet.
[00139] BY NITRIC OXIDE RADICAL ASSAY:
[00140] Preparation of test substance: 21mg of prepared polyherbal sugar free food supplement was dissolved separately in 1ml of DMSO to obtain the concentration of 1000µg/ml. Further the stock solution was serially diluted to obtain 1000 –62.5µg/ml to get the lower concentration.
[00141] Preparation of standard: 10mg of rutin was dissolved in 1ml of DMSO to obtain concentration of 1000µg/ml which was serially diluted to get lower conc. of 62.5, 125, 250,500 and 1000µg/ml.
[00142] Preparation of Sodium nitroprusside: In 100ml of distilled water, 0.29g of Sodium nitroprusside was dissolved.
[00143] Preparation of 0.1% NEDD: In 100ml of distilled water, 0.1g of NEDD was dissolved.
[00144] Preparation of Sulphanilic acid: In 100ml of 5% orthophosphoric acid, 1g of Sulphanilic acid was dissolved.
[00145] Nitric oxide radical assay procedure: In the test and test blank 0.1ml of test sample was taken and to this 0.4ml of 10mM Sodium nitroprusside, 0.1ml of PBS was added. For control and control blank 0.1ml of DMSO was taken in the place of test. For test blank and control blank 0.4ml of distilled water was added in place of Sodium nitroprusside. The reaction mixture was incubated at 250C for 150 minutes. After incubation 50µl of reaction mixture was transferred to microtiter plate and to this reaction mixture 0.1ml of Sulphanilic acid was added and kept for 5 minutes. Then 0.1ml of NEDD was added to all and allows it to stand for 30 minutes in diffused light. A pink coloured chromophore was formed according to the concentration of the test samples. Same procedure was repeated for standard by replacing the test sample with standard. Test and control were performed in triplicate and test blank and control blank were conducted in singlet. An antioxidant activity was determined by measuring the pink-coloured chromophore released from NEDD at 540nm in ELISA reader.
[00146] BY FERRIC ION REDUCING POWER ASSAY
[00147] Preparation of test substance: In 2ml of DMSO, 20mg of prepared polyherbal sugar free food supplement (test) is dissolved and kept overnight for complete dissolution to obtain the concentration of 1000µg/ml. Further the solution was serially diluted to obtain 1000 to 62.5µg/ml to get the lower concentration.
[00148] Preparation of standard: In 2ml of DMSO, 20mg of Ascorbic acid is dissolved to obtain solutions of 1000µg/ml which is serially dilute to get lower conc. of 62.5, 125, 250, 500 and 1000µg/ml.
[00149] Preparation of 1% Potassium ferric cyanide: In 100ml of distilled water, 1g of Potassium ferric cyanide is dissolved.
[00150] Preparation of 10% TCA: In 10ml of distilled water, 1ml of concentrated TCA was added and diluted.
[00151] Preparation of 0.1% Ferric chloride: In 100ml of distilled water, 0.1g of Ferric chloride was dissolved.
[00152] ABTS assay procedure: In test and test blank, 0.5ml of test substance (prepared polyherbal sugar free food supplement) was taken and to this 2.5ml of PBS was added and for test 2.5ml of potassium ferric cyanide was added further. For control and control blank, 0.5ml of DMSO was added in the place of test substance. For test blank and control blank, 2.5ml of distilled water was added in place of potassium ferric cyanide. The reaction mixture was incubated at 500? for 30 minutes. After incubation, 2.5ml of 10%TCA was added to the test and control and to the test blank and control blank 2.5ml of distilled water was added in place of TCA. The reaction mixture was centrifuged at 3000rpm for 10 minutes. 5ml of supernatant was mixed with equal volume of distilled water. Then 1ml of 0.1% FeCl3 was added to the test and control and distilled water was added to the test blank and control blank. The reaction mixtures were incubated at room temperature for 10 minutes. After incubation, 100µl of reaction mixture was transferred to microtiter plate. Same procedure was repeated for standard by replacing test sample with standard. Higher the absorbance represents the stronger reducing power. An antioxidant activity was determined by measuring the absorbance of samples at 700nm in ELISA reader.
RESULTS
[00153] PHYSIOCHEMICAL PARAMETER:
[00154] Description: the prepared polyherbal sugar free food supplement (test) was found to be semi-solid, chocolate-brown coloured sticky paste, taste sweet with non-specific pleasant odour.
[00155] Gallic acid content: The gallic acid content in the prepared polyherbal sugar free food supplement (test) was found to be 0.753% which was within predefined specification limit.
[00156] BY DPPH ASSAY:
[00157] Table 1 shows the antioxidant activity of the test substance by DPPH assay method. With respect to Table 1, the IC50 value for DPPH inhibition of the prepared polyherbal sugar free food supplement (test) was found to be 213.04±2.33µg/ml which is much higher than IC50 value for standard indicating that the prepared polyherbal sugar free food supplement (test) exhibits superior anti-oxidant property/activity. IC50 value is an indicative for anti-oxidant activity.
Table 1: The antioxidant activity of test substance for DPPH assay
S. No Test Substance Parameter IC50 (µg/ml)
1 Polyherbal sugar free food supplement (test) DPPH Assay 213.04±2.33
2 Ascorbic Acid (Standard) 97.78±0.32
[00158] FIG. 2A shows graphical representation of the percentage inhibition of DPPH by the ascorbic acid (standard) in a concentration dependent manner.
[00159] FIG. 2B shows graphical representation of the percentage inhibition of DPPH by the prepared polyherbal sugar free food supplement (test substance) in a concentration dependent manner.
[00160] With respect to FIG. 2A and FIG. 2B, the % inhibition of DPPH by prepared polyherbal sugar free food supplement (test substance) was found to be higher at 1000µg/ml concentration than standard indicating anti-oxidant property/activity of the prepared polyherbal sugar free food supplement (test).
[00161] BY ABTS ASSAY:
[00162] Table 2 shows the antioxidant activity of the test substance by ABTS assay method. With respect to Table 2, the IC50 value for ABTS inhibition of prepared polyherbal sugar free food supplement (test) was found to be >1000µg/ml which is much higher than the IC50 value for the standard indicating that the prepared polyherbal sugar free food supplement (test) exhibits superior anti-oxidant property/activity. IC50 value is an indicative for anti-oxidant activity.
Table 2: The antioxidant activity of test substance for ABTS assay
S. No Test Substance Parameter IC50 (µg/ml)
1 Polyherbal sugar free food supplement (test) ABTS Assay >1000
2 Ascorbic Acid (Standard) 66.57 ± 2.72
[00163] BY NITRIC OXIDE RADICAL ASSAY:
[00164] Table 3 shows the antioxidant activity of the test substance by Nitric oxide radical assay method. With respect to Table 3, the IC50 value by nitric oxide radical assay of prepared polyherbal sugar free food supplement (test) was found to be 200.53±2.92 which is much higher than the IC50 value for standard indicating that the prepared polyherbal sugar free food supplement (test) exhibits superior anti-oxidant property/activity. IC50 value is an indicative for anti-oxidant activity.
Table 3: The antioxidant activity of test substance for Nitric oxide radical assay
S. No Test Substance Parameter IC50 (µg/ml)
1 Polyherbal sugar free food supplement (test) Nitric oxide radical assay 200.53±2.92
2 Ascorbic Acid (Standard) 102.83 ± 2.87
[00165] FIG. 3A shows graphical representation of the percentage inhibition of nitric oxide by the ascorbic acid (standard) in a concentration dependent manner.
[00166] FIG. 3B shows graphical representation of the percentage inhibition of nitric oxide by the prepared polyherbal sugar free food supplement (test substance) in a concentration dependent manner.
[00167] With respect to FIG. 3A and FIG. 3B, the % inhibition of nitric oxide by prepared polyherbal sugar free food supplement (test substance) was found to be higher at 1000µg/ml concentration than standard indicating anti-oxidant property/activity of the prepared polyherbal sugar free food supplement (test substance).
[00168] BY FERRIC ION REDUCING POWER ASSAY
[00169] Table 4 shows the antioxidant activity of the test substance by ferric ion reducing power assay method. With respect to Table 4, the IC50 value by ferric ion reducing power assay of prepared polyherbal sugar free food supplement (test) was found to be >1000 which is much higher than the IC50 value for standard indicating that the prepared polyherbal sugar free food supplement (test) exhibits superior anti-oxidant property/activity. IC50 value is an indicative for anti-oxidant activity.
Table 4: The antioxidant activity of test substance for ferric ion reducing power assay
S. No Test Substance Parameter IC50 (µg/ml)
1 Polyherbal sugar free food supplement (test) Ferric ion reducing power assay >1000
2 Ascorbic Acid (Standard) 80.85 ± 6.01
G) ADVANTAGES OF INVENTION
[001] The present invention provides a polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual.The additive effect of ‘powdered admixture’ of fruit pulp aqueous extract of Emblica officinalis, green fruit extract of Artocarpus heterophyllus, dried roots extract of Glycyrrhiza glabra, fruit pulp extract of Phoenix dactylifera, a powdered blend of 34 other herbal extracts, a zero-calorie natural sweetener; a clarified butter; a cold press oil from seeds of Schistosoma indicum; a pharmaceutically acceptable excipient; and a powdered admixture of one or more herbal base additives comprising of fruit extract of Piper longum, stamen extract of Mesua ferrea, fruit extract of Elettaria cardamomum, leaf extract of Cinnamomum tamala, stem bark extract of Cinnamomum verum, and a silicate extract of Bamboo manna shows enhanced effect in people suffering with diabetes, obesity, cardiovascular disorders and other metabolic disorders.
[002] The polyherbal sugar free food supplement of the present invention possesses secondary metabolites including polyphenols, tannins, & flavonoids; and natural nutrients including vitamins, amino acids, fatty acids & minerals. The ‘synergistic effect’ of secondary metabolites and natural nutrients’ helps as health and immune supplement in boosting immunity in an individual.
[003] The polyherbal sugar free food supplement of the present invention is low caloric composition, diabetic friendly and good palatability.
[004] The polyherbal sugar free food supplement is eco-friendly since the ingredients utilized are natural and absolutely free from synthetic chemicals, added sugar, honey, added starch and artificial sweeteners.
[001] It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the claims presented in the complete specification or non-provisional application.
,CLAIMS:CLAIMS
We claim:
1. A polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual, comprises:
a) a ‘powdered admixture’ of fruit pulp aqueous extract of Emblica officinalis, green fruit extract of Artocarpus heterophyllus, dried roots extract of Glycyrrhiza glabra, and fruit pulp extract of Phoenix dactylifera;
b) a ‘powdered blend’ of 34 other plant extracts, wherein the said powdered blend of 34 other plant extracts comprises a stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera;
c) a zero-calorie natural sweetener;
d) a clarified butter;
e) a cold press oil from seeds of Schistosoma indicum;
f) a pharmaceutically acceptable excipient; and
g) one or more herbal base additives, wherein the herbal base additives are fruit extract of Piper longum, stamen extract of Mesua ferrea, fruit extract of Elettaria cardamomum, leaf extract of Cinnamomum tamala, stem bark extract of Cinnamomum verum, and a silicate extract of Bamboo manna.
2. The sugar free food supplement as claimed in claim 1,
wherein the fruit pulp aqueous extract of Emblica officinalis is present in an amount of 63.5% (w/w),
wherein the green fruit extract of Artocarpus heterophyllus is present in an amount of 2.0% (w/w),
wherein the dried roots extract of Glycyrrhiza glabra is present in an amount of 4.0% (w/w),
wherein the fruit pulp extract of Phoenix dactylifera is present in an amount of 22.14% (w/w).
3. The sugar free food supplement as claimed in claim 1, wherein the stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera is present in an amount of 50 grams each.
4. The sugar free food supplement as claimed in claim 1, wherein the zero-calorie natural sweetener is steviol, and wherein the zero-calorie natural sweetener is present in the amount of 0.20% (w/w).
5. The sugar free food supplement as claimed in claim 1, wherein the clarified butter is present in the amount of 2.0% (w/w), wherein the cold press oil from seeds of Schistosoma indicum is present in the amount of 2.0% (w/w).
6. The sugar free food supplement as claimed in claim 1, wherein the pharmaceutically acceptable excipient is citric acid, and wherein the pharmaceutically acceptable excipient is present in the amount of 0.75% (w/w).
7. The sugar free food supplement as claimed in claim 1, wherein the fruit extract of Piper longum, the stamen extract of Mesua ferrea, the fruit extract of Elettaria cardamomum, the leaf extract of Cinnamomum tamala, and the stem bark extract of Cinnamomum verum is present in the amount of 10 grams each.
8. The sugar free food supplement as claimed in claim 1, wherein the silicate extract of Bamboo manna is present in the amount of 100 grams.
9. A method of synthesizing a polyherbal sugar free food supplement for treating metabolic syndrome and boosting immunity in an individual, comprises:
(a) preparing an aqueous extract of fruit pulp of Emblica officinalis by dissolving the graded fruit pulp of Emblica officinalis in water, wherein the ratio of the graded fruit pulp of Emblica officinalis to water is 1:8 (101);
(b) preparing a ‘dried powdered admixture’ by blending a green fruit extract of Artocarpus heterophyllus, dried roots extract of Glycyrrhiza glabra, fruit pulp extract of Phoenix dactylifera with the aqueous extract of fruit pulp of Emblica officinalis of step (101) (102);
(c) preparing an aqueous extract of ‘powdered blend of 34 other plant extracts’, wherein the aqueous extract is obtained by dissolving the ‘powdered blend of 34 other plant extracts’ in water and spray dried (103);
(d) preparing a ‘dried powdered admixture’ of one or more herbal base additives (104);
(e) blending the dried powdered admixture of step (102), the aqueous extract of powdered blend of 34 other plant extracts of step (103), the dried powdered admixture of one or more herbal base additives of step (104), a zero-calorie natural sweetener, and a pharmaceutically acceptable excipient with a clarified butter and a cold press oil from seeds of Schistosoma indicum to obtain a mixture (105); and
(f) heating the mixture at 80 to 90°C under continuous stirring and cooled to obtain final product (106).
16. The method as claimed in claim 9, wherein the fruit pulp aqueous extract of Emblica officinalis is added in an amount of 63.5% (w/w), wherein the green fruit extract of Artocarpus heterophyllus is added in an amount of 2.0% (w/w), wherein the dried roots extract of Glycyrrhiza glabra is added in an amount of 4.0% (w/w), wherein the fruit pulp extract of Phoenix dactylifera is added in an amount of 22.14% (w/w).
17. The method as claimed in claim 9, wherein the said ‘powdered blend of 34 other plant extracts’ comprises a stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera.
18. The method as claimed in claim 17, wherein the stem or bark extract of Aegle marmelos, stem or bark extract of Clerodendrum phlomidis, stem or bark extract of Gmelina arborea, stem or bark extract of Oroxylum indicum, stem or bark extract of Stereospermum suaveolens, fruit extract of Tribulus terrestris, whole plant part extract of Desmodium gangeticum, whole plant part extract of Solanum indicum, whole plant part extract of Solanum surattense, gall extract of Pistacia integerrima, fruit extract of Vitis vinifera, pericarp extract of Terminalia chebula, stem extract of Tinospora cordifolia, whole plant part extract of Sida cordifolia, whole plant part extract of Phyllanthus niruri, root extract of Justicia adhatoda, root extract of Leptadenia reticulata, rhizome extract of Curcuma zedoaria, root extract of Inula racemose, rhizome extract of Cyperus rotundus, whole plant part extract of Phaseolus trilobus (Vigna trilobata), whole plant part extract of Termanus labialis, whole plant part extract of Desmodium gangeticum, whole plant part extract of Uraria picta, fruit extract of Piper longum, fruit extract of Martynia annua, root tuber extract of Dioscorea bulbifera, root tuber extract of Pueraria tuberosa, whole plant part extract of Boerhavia diffusa, flower extract of Nymphaea nouchali, heartwood extract of Aquilaria agallocha, heartwood extract of Santalum album, root extract of Asparagus racemosus, and root extract of Withania somnifera is added in an amount of 50 grams each.
19. The method as claimed in claim 9, wherein the ratio of the ‘powdered blend of 34 other plant extracts’ to water is 1:10.
20. The method as claimed in claim 9, wherein the herbal base additives are fruit extract of Piper longum, stamen extract of Mesua ferrea, fruit extract of Elettaria cardamomum, leaf extract of Cinnamomum tamala, stem bark extract of Cinnamomum verum, and a silicate extract of Bamboo manna, and wherein the fruit extract of Piper longum, stamen extract of Mesua ferrea, fruit extract of Elettaria cardamomum, leaf extract of Cinnamomum tamala, and stem bark extract of Cinnamomum verum is added in an amount of 10 grams each, and wherein the silicate extract of Bamboo manna is added in an amount of 100 grams.
21. The method as claimed in claim 9, wherein the zero-calorie natural sweetener is steviol, and wherein the said zero-calorie natural sweetener is present in the amount of 0.20% (w/w), wherein the clarified butter is present in the amount of 2.0% (w/w), and wherein the cold press oil from seeds of Schistosoma indicum is present in the amount of 2.0% (w/w).
22. The method as claimed in claim 9, wherein the pharmaceutically acceptable excipient is citric acid, and wherein the pharmaceutically acceptable excipient is present in the amount of 0.75% (w/w).
| # | Name | Date |
|---|---|---|
| 1 | 202241013542-PROVISIONAL SPECIFICATION [12-03-2022(online)].pdf | 2022-03-12 |
| 2 | 202241013542-POWER OF AUTHORITY [12-03-2022(online)].pdf | 2022-03-12 |
| 3 | 202241013542-FORM FOR SMALL ENTITY(FORM-28) [12-03-2022(online)].pdf | 2022-03-12 |
| 4 | 202241013542-FORM FOR SMALL ENTITY [12-03-2022(online)].pdf | 2022-03-12 |
| 5 | 202241013542-FORM 1 [12-03-2022(online)].pdf | 2022-03-12 |
| 6 | 202241013542-FIGURE OF ABSTRACT [12-03-2022(online)].jpg | 2022-03-12 |
| 7 | 202241013542-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [12-03-2022(online)].pdf | 2022-03-12 |
| 8 | 202241013542-EVIDENCE FOR REGISTRATION UNDER SSI [12-03-2022(online)].pdf | 2022-03-12 |
| 9 | 202241013542-DRAWINGS [12-03-2022(online)].pdf | 2022-03-12 |
| 10 | 202241013542-DECLARATION OF INVENTORSHIP (FORM 5) [12-03-2022(online)].pdf | 2022-03-12 |
| 11 | 202241013542-DRAWING [09-03-2023(online)].pdf | 2023-03-09 |
| 12 | 202241013542-COMPLETE SPECIFICATION [09-03-2023(online)].pdf | 2023-03-09 |
| 13 | 202241013542-MSME CERTIFICATE [22-07-2024(online)].pdf | 2024-07-22 |
| 14 | 202241013542-FORM28 [22-07-2024(online)].pdf | 2024-07-22 |
| 15 | 202241013542-FORM 18A [22-07-2024(online)].pdf | 2024-07-22 |
| 16 | 202241013542-RELEVANT DOCUMENTS [19-12-2024(online)].pdf | 2024-12-19 |
| 17 | 202241013542-POA [19-12-2024(online)].pdf | 2024-12-19 |
| 18 | 202241013542-FORM 13 [19-12-2024(online)].pdf | 2024-12-19 |