Description:FIELD OF THE INVENTION
[0001] The present disclosure relates to a herbal composition. The present disclosure also relates to a method of preparation of a herbal composition. The herbal composition is used for reducing obesity.

BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Obesity is an endocrine and heritable disorder, which results in excessive or abnormal adipose tissue/fat accumulation in the body. It is a complex and a multifactorial disease that can cause health impairment. Imbalance between daily energy intake and expenditure results leads to excessive weight gain. Obesity has become a significant epidemic which has progressively worsened over past decades, raising the risk of chronic ailments such as hypertension, diabetes, cardiovascular disease, cancer, inflammatory diseases etc. [Blüher M., Nat. Rev. Endocrinol., 2019, 15, 288-98].
[0004] An obesity prevalence is alarmingly on the rise in both developed and developing nations. As per WHO report, worldwide more than 1 billion people are obese. In India, over 135 million people are living with obesity; which is attributed to rapid urbanization and industrialization. Although, after smoking it is the second most common preventable cause of death [Ahirwar et al., Diabetes Metab Syndr. 2019, 13, 318-321].
[0005] Family genetics plays a crucial role in developing obesity. Intake of high calorie food like excessive carbohydrates & sugar, ultra-processed foods with low or no nutritional content, decreased physical activity, sedentary lifestyle, poor sleep, poverty, certain medical conditions and medicines as well as environmental factors such as workplace environment and long working hours are some of the common etiological factors for obesity. It has been associated with increased risk of development and progression of type 2 diabetes mellitus, cardiovascular disease, hypertension, hyperlipidemia and higher mortality rates [Blüher M., Nat. Rev. Endocrinol., 2019, 15, 288-98; Omer T., Adv Obes Weight Manag Control 2020, 10, 90-94].
[0006] Hypothyroidism has been closely associated with obesity. Thyroid hormones play an important role in lipid and glucose metabolism, food intake and fat oxidation. Thyroid dysfunction may result in body weight changes and composition, and total and resting energy expenditure. Research suggests that, in addition to decreasing thermogenesis and metabolic rate, hypothyroidism is associated with significant increase in body mass index (BMI) and obesity prevalence. Clinical evidence indicates that weight loss induces a significant improvement in thyroid function [Sanyal et al., Indian J Endocrinol Metab. 2016, 20, 554-7; Ríos-Prego et al., Int J Gen Med. 2019, 23, 299-304].
[0007] Multidisciplinary approach is required in the battle against obesity, such as clinical, dietary, and pharmacological approaches. Clinical approaches include surgery, lifestyle changes, and physical activity [Alfaifi et al., Cureus, 2020, 11, 12(10), e10903]. Dietary approaches contain caloric restriction and weight-loss diet. Pharmacological approaches comprise several weight-loss drugs. Bariatric surgery and only a few approved drug therapies are effective ways to induce body weight loss [Müller et al. Nat Rev Drug Discov., 2022, 21, 201–223]. Wholesome approach that is diet, exercise, nutritional awareness, and a healthy psychological state of mind all contribute to a favorable environment in managing healthy weight.
[0008] Plant-herbal drugs have gained much attention as a reliable alternative to anti-obesity drugs, because of the side effects encountered with long time usage of synthetic drugs and stringent guidelines during drug approvals. Recently, claims and demand for herbal remedies has grown significantly. Phytochemicals found in food items and herbal preparations have potential to alter appetite beyond their nutritional loading effects. This, along with the fact that they have significantly fewer adverse effects, may provide an alternative treatment approach. Incorporating small changes in behavior, such as increasing physical exercise, eating a balanced diet, and supplementing with nutrients from nutraceutical goods or herbal juice, can help in preventing weight gain in the majority of the individuals. The addition of nutraceuticals into diet can help people control and maintain their weight. Additionally, it can mitigate the physical, social, and psychological burden imposed by obesity [Kumar et al., Evid Based Complement Alternat Med., 2022, 2022, 1-20; Tucci et al., Pharmaceuticals. 2010, 3(3), 748-763].
[0009] Park et al. [Biomed Res Int., 2020, 2020, 3891806] discloses that microinjection of berberine in the hypothalamus region in rats reduced food intake and glucose increases. The results suggest that BBR improved lipid dysregulation in obesity by controlling the central obesity-related pathway.
[0010] Kumari et al. [Ayushdhara, 2018, 5, 1597-1608] discloses a clinical study to compare the effect of lekhniya mahakashay through oral administration and sarwang swedan in cases of sthaulya w.s.r to obesity.
[0011] Khandekar et al. [Int J Herb Med, 2019, 7, 31-35] reported that Katuka is useful in obesity associated with comorbidities like cardiac disorders, hyperlipidemia, diabetes, liver disease and cancer. This review paper presents its role in obesity on the basis of ayurvedic and modern parameters.
[0012] Majeed et al. [Diabetes Metab Syndr Obes. 2022, 15, 369–382] evaluated the efficacy and safety of Cyperus rotundus rhizome extract (CRE), standardized to contain Piceatannol, Scirpusin A, and Scirpusin B (5% total Stilbenoids) in overweight individuals. In conclusion, CRE has anti-adipogenic properties, is safe for human consumption, and effectively manages weight and hypercholesterolemia in overweight individuals.
[0013] Sansare et al. [Altern Integ Med 2013, 2, 10] discloses that the herbal drugs (haridra and chitrak) are effective against cardinal as well as general signs and symptoms of medovriddhi (hyperlipidaemia) in patients. In the clinical study, efficacy of chitrak is better than haridra in the alleviation of symptoms of medovriddhi.
[0014] Fakhr et al. [Pharmacol Res., 2023, 187, 106594, 1-13] discloses that administration of fenugreek can meaningfully reduce FPG, TG, WC, and SBP and increase HDL. The overall results support possible protective and therapeutic effects of fenugreek on metabolic syndrome (MetS) parameters.
[0015] Makihara et al. [Biol. Pharm. Bull. 2016, 39, 1137–1143] discloses that gallic acid is one of the active constituents of Terminalia bellirica (TB) and that it enhanced the expression and secretion of adiponectin in adipocytes. These findings serve as a foundation for further investigations on the potential of gallic acid and TB to prevent and treat metabolic syndrome.
[0016] Shirolkar et al. [J. Diabetes Metab. Disord, 2020, 19, 1367-1379] discloses that Tinospora cordifolia (TC) is a well-known Ayurvedic drug and a rich source of protoberberine alkaloids hence can contribute to triglyceride lowering without side effects. Tinospora cordifolia extract administration depleted the levels of markers of HG i.e. VLDL, TG, and LDL significantly. Metabolomics studies established that the anti-HG activity of TCE was due to its antioxidative potential and modulation of the biopterin, butanoate, amino acid, and vitamin metabolism.
[0017] M. B. Kavita et al. [Int. J. Res Ayurved Pharm, 2016, 7, 59-64] discloses a clinical study on effect of amalaki (indian gooseberry) as food supplement in dyslipidemia. The study concludes that administration of Amalaki Choorna (powder of Emblica officinalis Garten) is a possible food supplement of choice that manages dyslipidemia significantly without causing any adverse effects.
[0018] Keramati et al. [J Food Biochem, 2022, 46, e14166] reviewed that cinnamon, an effective anti-obesity agent. It is reported that a comprehensive study was performed on meta-analyses performed on the effect of cinnamon on anthropometric indices. This study could be considered as a final conclusion about the effect of cinnamon on anthropometric indices. The result of this study showed that supplementation with cinnamon significantly reduces BMI and body weight.
[0019] Lailiyah et al. [JSMARTech, 2021, 2, 101-106] determined the potential of piperine and piperidine as major compounds in pepper as GHSR-Ghrelin inhibitors due to over-activity of Ghrelin as appetite hormone in obesity. The conclusion of the present study is that the piperine may act as an inhibitor of GHSR-Ghrelin interaction to prevent appetite behavior resulting in bodyweight loss in obesity.
[0020] Zare et al. [Complement. Ther. Clin. Pract., 2014, 20, 297-301] discloses effect of cumin powder on body composition and lipid profile in overweight and obese women. Results showed that cumin powder reduced serum levels of fasting cholesterol, triglyceride, and LDL and increased HDL. Weight, BMI, waist circumference, fat mass and its percentage significantly reduced. It has no effect on FBS and fat-free mass. Thus, Cumin powder in a weight reduction diet showed improvement in anthropometric and biochemical parameters in overweight/obese women.
[0021] Attari et al. [Phyother Res 2018, 32, 577-585] discloses that ginger could modulate obesity through various potential mechanisms including increasing thermogenesis, increasing lipolysis, suppression of lipogenesis, inhibition of intestinal fat absorption, and controlling appetite. This review article provides some convincing evidence to support the efficacy of ginger in obesity management and demonstrates the importance of future clinical trials.
[0022] At present, proprietary Ayurvedic blends are present for weight management. However, they might not employ the right methods and concentrations/actives in ingredients to provide maximum efficacy.
[0023] The plant-herbal drugs have gained much attention as a reliable alternative to anti-obesity drugs, because of the side effects encountered with long time usage of synthetic drugs and stringent guidelines during drug approvals. Recently, claims and demand for herbal remedies has grown significantly. Phytochemicals found in food items and herbal preparations have potential to alter appetite beyond their nutritional loading effects. This, along with the fact that they have significantly fewer adverse effects, may provide an alternative treatment approach.
[0024] Thus, there is a need to develop a herbal composition for weight management which can effectively reduces body weight without side effects. The present disclosure has chosen the best methods and technologies to improve efficacy of herbal composition. Ingredient-wise, the present disclosure has chosen the right actives and extracts in appropriate concentrations to provide maximum efficacy.

OBJECTS OF THE INVENTION
[0025] An object of the present disclosure is to provide a herbal composition.
[0026] Another object of the present disclosure is to provide a method of preparation of a herbal composition.

BRIEF DESCRIPTION OF THE DRAWINGS
[0027] Figure 1: Graph depicting the reducing trend in body weight after treatment with Get slim juice in obese subjects.
[0028] Figure 2: Graph depicting reducing trend in body weight after treatment with Get slim juice in obese subjects with hypothyroidism.

SUMMARY OF THE INVENTION
[0029] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in Detailed Description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
[0030] An aspect of the present disclosure relates to a herbal composition having 0.1 to 2 % w/v of Berberis aristatsa of the total composition; 0.1 to 1 % w/v of Gymnema sylvestre of the total composition; 0.1 to 2 % w/v of Curcuma longa of the total composition; 0.1 to 2 % w/v of Terminalia chebula of the total composition; 0.01 to 0.5 % w/v of Picrorhiza kurroa of the total composition; 0.01 to 0.5 % w/v of Cyprus Rotundus of the total composition; 0.01 to 0.5 % w/v of Plumbago zeylanica of the total composition; 0.1 to 2 % w/v of Trigonella foenum graecum of the total composition; 0.1 to 2 % w/v of Terminalia bellirica of the total composition; 0.1 to 2 % w/v of Tinospora cordifolia of the total composition; 0.01 to 0.5 % w/v of Zingiber officinale of the total composition; 0.1 to 2 % w/v of Garcinia cambogia of the total composition; 10 to 20 % w/v of Emblica officinalis of the total composition; 0.01 to 0.5 % w/v of Cinnamomum zeylanicum of the total composition; 0.001 to 0.1 % w/v of Piper nigrum of the total composition; 0.01 to 0.5 % w/v of Cuminum cyminum of the total composition; and 0.5 to 4 % w/v of a pharmaceutical excipient of the total composition.
[0031] Another aspect of the present disclosure relates to a method of preparation of a herbal composition having a) making kwath by decoction of 0.1 to 2 % w/v of Berberis aristatsa; 0.1 to 1 % w/v of Gymnema sylvestre; 0.1 to 2 % w/v of Curcuma longa; 0.1 to 2 % w/v of Terminalia chebula; 0.01 to 0.5 % w/v of Picrorhiza kurroa; 0.01 to 0.5 % w/v of Cyprus Rotundus; 0.01 to 0.5 % w/v of Plumbago zeylanica; 0.1 to 2 % w/v of Terminalia bellirica; 0.1 to 2 % w/v of Tinospora cordifolia; 0.01 to 0.5 % w/v of Cinnamomum zeylanicum; 0.001 to 0.1 % w/v of Piper nigrum; and 0.01 to 0.5 % w/v of Cuminum cyminum in a solvent under condition to obtain an kwath of each herb respectively; b) filterning the kwath of each herb through muslin cloth to remove the residual herbs and to obtain an kwath extract; c) extracting the 0.1 to 2 % w/v of Trigonella foenum graecum; 0.1 to 2 % w/v of Garcinia cambogia; and 0.01 to 0.5 % w/v of Zingiber officinale to obtain the extract of fenugreek , garcinia and ginger; d) adding 10 to 20 % w/v of an Emblica officinalis swaras to the extract obtained from step b) and c) to form a mixture; and e) mixing 0.5 to 4 % w/v of a pharmaceutical excipient with the mixture of step d) under condition to obtain a herbal composition.
[0032] Other aspects of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learnt by the practice of the invention.

DETAILED DESCRIPTION OF THE INVENTION
[0033] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure.
[0034] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[0035] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0036] In some embodiments, numbers have been used for quantifying weights, percentages, ratios, and so forth, to describe certain embodiments of the invention and are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[0037] Various terms as used herein are shown below. To the extent a term used is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[0038] As used in the description herein that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[0039] Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”
[0040] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.
[0041] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention.
[0042] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified.
[0043] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[0044] It should also be appreciated that the present disclosure can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention.
[0045] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0046] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus, if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[0047] An embodiment of the present disclosure provides a herbal composition comprising: 0.1 to 2 % w/v of Berberis aristatsa of the total composition; 0.1 to 1 % w/v of Gymnema sylvestre of the total composition; 0.1 to 2 % w/v of Curcuma longa of the total composition; 0.1 to 2 % w/v of Terminalia chebula of the total composition; 0.01 to 0.5 % w/v of Picrorhiza kurroa of the total composition; 0.01 to 0.5 % w/v of Cyprus Rotundus of the total composition; 0.01 to 0.5 % w/v of Plumbago zeylanica of the total composition; 0.1 to 2 % w/v of Trigonella foenum graecum of the total composition; 0.1 to 2 % w/v of Terminalia bellirica of the total composition; 0.1 to 2 % w/v of Tinospora cordifolia of the total composition; 0.01 to 0.5 % w/v of Zingiber officinale of the total composition; 0.1 to 2 % w/v of Garcinia cambogia of the total composition; 10 to 20 % w/v of Emblica officinalis of the total composition; 0.01 to 0.5 % w/v of Cinnamomum zeylanicum of the total composition; 0.001 to 0.1 % w/v of Piper nigrum of the total composition; 0.01 to 0.5 % w/v of Cuminum cyminum of the total composition; and 0.5 to 4 % w/v of a pharmaceutical excipient of the total composition.
[0048] In an embodiment, the pharmaceutical excipient is selected from a group consisting of dispersing agent, solubilising agent, emulsifying agent, suspending agent, thickening agent, preservatives, sweetening agent, coloring agent and combination thereof. In some embodiment, the pharmaceutical excipient is selected from calcium propionate, potassium sorbate, Sodium benzoate, sodium metabisulphite, carboxy methyl cellulose, cargeenan, agar, xanthum gum and combination thereof.
[0049] In an embodiment, the herbal composition is administered orally. The herbal composition has a form selected from the group consisting of emulsion, suspension, syrup, solution and juice, preferably the herbal composition is a juice. The herbal composition is taken in an amount in the range between 10 to 50 ml per day, preferably the amount is 20 to 40 ml per day, more preferably the amount is 25 to 35 ml per day. The herbal composition is taken twice in a day.
[0050] In an embodiment, the herbal composition is an oral herbal composition. The oral herbal composition comprising: 0.5 to 1.5 % w/v of Berberis aristatsa of the total composition; 0.3 to 0.8 % w/v of Gymnema sylvestre of the total composition; 0.5 to 1.5 % w/v of Curcuma longa of the total composition; 0.5 to 1.5 % w/v of Terminalia chebula of the total composition; 0.05 to 0.3 % w/v of Picrorhiza kurroa of the total composition; 0.05 to 0.3 % w/v of Cyprus Rotundus of the total composition; 0.05 to 0.3 % w/v of Plumbago zeylanica of the total composition; 0.1 to 1 % w/v of Trigonella foenum graecum of the total composition; 0.1 to 1 % w/v of Terminalia bellirica of the total composition; 0.1 to 1 % w/v of Tinospora cordifolia of the total composition; 0.01 to 0.2 % w/v of Zingiber officinale of the total composition; 0.1 to 1 % w/v of Garcinia cambogia of the total composition; 13 to 18 % w/v of Emblica officinalis of the total composition; 0.01 to 0.2 % w/v of Cinnamomum zeylanicum of the total composition; 0.001 to 0.05 % w/v of Piper nigrum of the total composition; 0.01 to 0.2 % w/v of Cuminum cyminum of the total composition; and 1 to 2 % w/v of a pharmaceutical excipients of the total composition.
[0051] An embodiment of the present disclosure provides a method of preparation of a herbal composition comprising: a) making kwath by decoction of 0.1 to 2 % w/v of Berberis aristatsa; 0.1 to 1 % w/v of Gymnema sylvestre; 0.1 to 2 % w/v of Curcuma longa; 0.1 to 2 % w/v of Terminalia chebula; 0.01 to 0.5 % w/v of Picrorhiza kurroa; 0.01 to 0.5 % w/v of Cyprus Rotundus; 0.01 to 0.5 % w/v of Plumbago zeylanica; 0.1 to 2 % w/v of Terminalia bellirica; 0.1 to 2 % w/v of Tinospora cordifolia; 0.01 to 0.5 % w/v of Cinnamomum zeylanicum; 0.001 to 0.1 % w/v of Piper nigrum; and 0.01 to 0.5 % w/v of Cuminum cyminum in a solvent under condition to obtain an kwath of each herb respectively; b) filterning the kwath of each herb through muslin cloth to remove the residual herbs and to obtain an kwath extract; c) extracting the 0.1 to 2 % w/v of Trigonella foenum graecum; 0.1 to 2 % w/v of Garcinia cambogia; and 0.01 to 0.5 % w/v of Zingiber officinale to obtain the extract of fenugreek , garcinia and ginger; d) adding 10 to 20 % w/v of an Emblica officinalis swaras to the extract obtained from step b) and c) to form a mixture; and e) mixing 0.5 to 4 % w/v of a pharmaceutical excipient with the mixture of step d) under condition to obtain a herbal composition.
[0052] In an embodiment, the solvent is water.
[0053] In an embodiment, the decoction is carried out at a temperature in the range of 70 to 80 °C for a period reducing the volume to half and mixing of step e) is carried out at a temperature in the range of 20 to 35°C until the mixture is homogenously mixed.
[0054] In an embodiment, the combination of herbal composition of the present disclosure with moderate lifestyle change in diet and lifestyle will have a synergistic effect on managing body weight. The herbal composition of the present disclosure contains herbal extracts, such as daru haldi, gurmar, haldi, haritaki, kutki, musta, chitrak mool, fenugreek, bibhitaki, giloy, ginger, garcinia, amla, cinnamon, black pepper, cumin which has been proven ingredient which will aid in the weight management by regulating the appetite, improving metabolism, reducing hunger cravings and burning fat. The herbal composition of the present disclosure was employed as an exploratory product in the current study to confirm its safety and efficacy in weight management.
[0055] The active herbs of the herbal composition of the present invention were procured from the vendors. The geographical locations of the active herbs are given in the below Table 1:
[0056] Table 1: Geographical details of the herbs of the herbal composition of the present invention.
S. No. Scientific Name of the Biological Resource Common Name of the Biological Resource Part Used Exact Geographical Location of the access of the Biological Resources
1. Emblica officinalis Amalaki Fresh Fruit Pratapgarh, Rajasthan
2. Berberis aristata Daruharidra Stem Nilgiri Hills South India
3. Terminalia chebula Haritaki Fruit Pericarp Forest of M.P. & Chattisgarh
4. Tinospora cordifolia Guduchi Stem Assam, West Bengal
5. Curcuma longa Haridra Rhizome South India
6. Trigonella foenum graecum Methi Seed Rajasthan
7. Terminalia bellirica Bibhitaka Fruit Pericarp Forest of M.P. & Chattisgarh
8. Gymnema sylvestre Meshashringi Leaf M.P. & Chattisgarh
9. Cyperus rotundus Musta Rhizome M.P. & Chattisgarh
10. Plumbago zeylanica Chitraka Root M.P. & Chattisgarh
11. Picrorhiza kurroa Katuka Rhizome North Western Himalayas, Kashmir to Sikkim
12. Cinnamomum zeylanicum Tvak Bark Western Ghat & Adjoining Hills
13. Cuminum cyminum Svetajiraka Fruit Western Rajasthan & Gujrat
14. Piper nigrum Marica Fruit North Konkan Kerala, Assam
15. Zingiber officinale Sunthi Rhizome Karnatak, Orissa, Assam, Meghalaya
16. Garcinia
Cambogia Vrikshamla Fruit South India

[0057] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

EXAMPLES
[0058] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may vary.
Example 1
[0059] The herbal composition of the present invention having the amount in given in Table 2:
[0060] Table 2: Herbal composition of the present invention.
Sr. No. Name of the Ingredient Scientific Name Composition(g) in 1000 ml
1 Daru Haldi Berberis aristatsa 10
2 Gurmar Gymnema sylvestre 4.5
3 Haldi Curcuma longa 8
4 Haritaki Terminalia chebula 10
5 Kutki Picrorhiza kurroa 1
6 Musta Cyprus Rotundus 2
7 Chitrak Mool Plumbago zeylanica 1.5
8 Fenugreek Trigonella foenum graecum 7
9 Bibhitaki Terminalia bellirica 5
10 Giloy Tinospora cordifolia 9
11 Ginger Zingiber officinale 0.2
12 Garcinia Extract Garcinia cambogia 5
13 Amla Juice Emblica officinalis 150
14 Cinnamon Cinnamomum zeylanicum 1
15 Black Pepper Piper nigrum 0.1
16 Cumin Cuminum cyminum 1
17 Calcium propionate 2
18 Potassium sorbate 10
Example 2
[0061] The physico-chemical analysis of the prepared herbal composition of Example 1 is given in the below Table 3. The physico-chemical paremeters such as pH, specific gravity, total solids are within the range of the standard. Further, microbiological analysis is also as per the standard.

[0062] Table 3: Physico-chemical analysis of prepared herbal composition.
Parameters Standard Result UOM Test method
Physico-Chemical Analysis
Description Brown Colored Liquid Complies - In House AD/STP/88/00
pH 3.0-7.0 3.34 - API Part-I Vol. IX 2016
Specific Gravity NLT 0.9 1.0088 API Part-I Vol. IX 2016
Total Solids NLT 3.0 3.82 % w/w API Part-I Vol. IX 2016
Microbiological Analysis
Total Aerobic Microbial Count <100000 <10 Cfu/ml API Part-I Vol. IX 2016
Total Fungal Count <1000 <10 Cfu/ml API Part-I Vol. IX 2016
Escherichia Coli Absent Absent Per ml API Part-I Vol. IX 2016
Salmonella Absent Absent Per ml API Part-I Vol. IX 2016
Staphylococcus aureus Absent Absent Per ml API Part-I Vol. IX 2016
Pseudomonas aeruginosa Absent Absent Per ml API Part-I Vol. IX 2016

Example 3:
[0063] A group of 15 patients (overweight to obese) was taken to determine the effectiveness of the herbal composition as defined in Example 1. The efficacy of the herbal composition of the present invention in the management of weight was determined by comparing pre- and post-treatment status of the patients from the same group and between the groups as well. A 30 ml of herbal composition was diluted with 200 ml of normal or luke water and was given twice a day (one hour before meals) to the patients. Assessment of body weight, BMI, digestive behavior and general complaint assessment based on VAS were carried out.
[0064] In the present study, the initial body weight of the obese subjects was 82.81 kg and BMI was 27.95 kg/m2, after treatment with herbal composition of the present invention, at day 90 there was around 7.06 kg of reduction of body weight to average of 75.76 kg with BMI of 25.57. The reduction in body weight observed in the study was statistically significant (p<0.001). A significant reduction was seen in just 15 days and the trend continued till day 90 as shown in Table 4 and Figure 1.
[0065] Table 4: Anthropometric assessment of obese subjects.

[0066] In obese subjects, after treatment with the herbal composition of the present invention, there was a significant reduction in anthropometric parameters such as waist, hip, and mid-arm circumference along with the body fat and visceral fat % through the impedance technique (Table 5).
[0067] Table 5: Anthropometric assessment of obese subjects.

Example 4:
[0068] A group of 15 patients (overweight to obese) with hypothyroidism was taken to determine the effectiveness of the herbal composition as disclosed in Example 1. The efficacy of the herbal composition of the present invention in the management of weight was determined by comparing pre- and post-treatment status of the patients from the same group and between the groups as well. A 30 ml of herbal composition was diluted with 200 ml of normal or luke water and was given twice a day (one hour before meals) to the patients. Assessment of body weight, BMI, digestive behavior and general complaint assessment based on VAS were carried out.
[0069] In the present study, the initial body weight of the obese subjects with hypothyroidism were 81.13 kg and BMI was 30.36 kg/m2, after treatment with herbal composition of the present invention, at day 90 there was around 5.68 kg of reduction of body weight to average 75.56 kg with BMI of 28.23. The reduction in body weight observed in the study was statistically significant (p<0.001). The significant reduction was seen in just 15 days and the trend continued till day 90 as shown in Table 6 and Figure 2.
[0070] Table 6: Anthropometric assessment of obese subjects with hypothyroidism.

[0071] In obese subjects with hypothyroidism, after treatment with the herbal composition of the present invention, there was a significant reduction in anthropometric parameters such as waist, hip, and mid-arm circumference along with the body fat and visceral fat % through the impedance technique (Table 7).
[0072] Table 7: Anthropometric assessment of obese subjects with hypothyroidism.

Example 5
[0073] The stability testing was carried out on the herbal composition of the present invention for 3 months as shown in Table 8. The data indicates that the herbal composition was stable after 3 months. Further, the obtained results indicate that the herbal composition was stable after 6 months. Based on 6 months accelerated stability data, the shelf life of the herbal composition of present application can be given as 18-24 months from the date of manufacture.
[0074] Table 8: Stability data of the herbal composition.
S. No. Particular Test method Specification UOM 0 Days 3 Month
Physico-Chemical Analysis
1 Description In House AD/STP/68/00 Brown Colored Liquid - Brown Colored Liquid Brown Colored Liquid
2 pH API Part II Vol. IV 3.0-6.0 - 3.44 3.49
3 Specific Gravity API Part II Vol. IV NLT 0.9 - 1.0164 1.0158
4 Total Solids API Part II Vol. IV NLT 3.0 % w/w 3.61 3.65
Microbiological Analysis
5 Total Aerobic Microbial Count API Part II Vol. IV <100000 Cfu/ml 350 380
6 Total Fungal Count API Part II Vol. IV <1000 Cfu/ml <10 <10
7 Escherichia Coli API Part II Vol. IV Absent Per ml Absent Absent
8 Salmonella API Part II Vol. IV Absent Per ml Absent Absent
9 Staphylococcus aureus API Part II Vol. IV Absent Per ml Absent Absent
10 Pseudomonas aeruginosa API Part II Vol. IV Absent Per ml Absent Absent
[0075] This invention has been described in terms of specific embodiments set forth in detail, but it should be understood that these are by way of illustration only and that the invention is not necessarily limited thereto. Modifications and variations will be apparent from this disclosure and may be achieved without departing from the scope of this invention, as those skilled in the art will readily understand. Accordingly, such variations and modifications of the disclosed embodiments are considered to be within the purview and scope of this invention and the following claims.
, Claims:
1. A herbal composition comprising:
0.1 to 2 % w/v of Berberis aristatsa of the total composition;
0.1 to 1 % w/v of Gymnema sylvestre of the total composition;
0.1 to 2 % w/v of Curcuma longa of the total composition;
0.1 to 2 % w/v of Terminalia chebula of the total composition;
0.01 to 0.5 % w/v of Picrorhiza kurroa of the total composition;
0.01 to 0.5 % w/v of Cyprus Rotundus of the total composition;
0.01 to 0.5 % w/v of Plumbago zeylanica of the total composition;
0.1 to 2 % w/v of Trigonella foenum graecum of the total composition;
0.1 to 2 % w/v of Terminalia bellirica of the total composition;
0.1 to 2 % w/v of Tinospora cordifolia of the total composition;
0.01 to 0.5 % w/v of Zingiber officinale of the total composition;
0.1 to 2 % w/v of Garcinia cambogia of the total composition;
10 to 20 % w/v of Emblica officinalis of the total composition;
0.01 to 0.5 % w/v of Cinnamomum zeylanicum of the total composition;
0.001 to 0.1 % w/v of Piper nigrum of the total composition;
0.01 to 0.5 % w/v of Cuminum cyminum of the total composition; and
0.5 to 4 % w/v of a pharmaceutical excipient of the total composition.
2. The herbal composition as claimed in claim 1, wherein the pharmaceutical excipient is selected from a group consisting of dispersing agent, solubilising agent, emulsifying agent, suspending agent, thickening agent, preservatives, sweetening agent, coloring agent and combination thereof.
3. The herbal composition as claimed in claim 2, wherein the pharmaceutical excipient is selected from calcium propionate, potassium sorbate, Sodium benzoate, sodium metabisulphite, carboxy methyl cellulose, cargeenan, agar, xanthum gum and combination thereof.
4. The herbal composition as claimed in claim 1, wherein the herbal composition is administered orally.
5. The herbal composition as claimed in claim 1, wherein the herbal composition has a form selected from the group consisting of emulsion, suspension, syrup, solution and juice.
6. The herbal composition as claimed in claim 1, wherein the herbal composition is administered in an amount in the range between 10 to 50 ml per day.
7. The herbal composition as claimed in claim 1, wherein the herbal composition is an oral herbal composition comprising:
0.5 to 1.5 % w/v of Berberis aristatsa of the total composition;
0.3 to 0.8 % w/v of Gymnema sylvestre of the total composition;
0.5 to 1.5 % w/v of Curcuma longa of the total composition;
0.5 to 1.5 % w/v of Terminalia chebula of the total composition;
0.05 to 0.3 % w/v of Picrorhiza kurroa of the total composition;
0.05 to 0.3 % w/v of Cyprus Rotundus of the total composition;
0.05 to 0.3 % w/v of Plumbago zeylanica of the total composition;
0.1 to 1 % w/v of Trigonella foenum graecum of the total composition;
0.1 to 1 % w/v of Terminalia bellirica of the total composition;
0.1 to 1 % w/v of Tinospora cordifolia of the total composition;
0.01 to 0.2 % w/v of Zingiber officinale of the total composition;
0.1 to 1 % w/v of Garcinia cambogia of the total composition;
13 to 18 % w/v of Emblica officinalis of the total composition;
0.01 to 0.2 % w/v of Cinnamomum zeylanicum of the total composition;
0.001 to 0.05 % w/v of Piper nigrum of the total composition;
0.01 to 0.2 % w/v of Cuminum cyminum of the total composition; and
1 to 2 % w/v of a pharmaceutical excipients of the total composition.
8. A method of preparation of a herbal composition comprising:
a) making kwath by decoction of 0.1 to 2 % w/v of Berberis aristatsa; 0.1 to 1 % w/v of Gymnema sylvestre; 0.1 to 2 % w/v of Curcuma longa; 0.1 to 2 % w/v of Terminalia chebula; 0.01 to 0.5 % w/v of Picrorhiza kurroa; 0.01 to 0.5 % w/v of Cyprus Rotundus; 0.01 to 0.5 % w/v of Plumbago zeylanica; 0.1 to 2 % w/v of Terminalia bellirica; 0.1 to 2 % w/v of Tinospora cordifolia; 0.01 to 0.5 % w/v of Cinnamomum zeylanicum; 0.001 to 0.1 % w/v of Piper nigrum; and 0.01 to 0.5 % w/v of Cuminum cyminum in a solvent under condition to obtain an kwath of each herb respectively;
b) filterning the kwath of each herb through muslin cloth to remove the residual herbs and to obtain an kwath extract;
c) extracting the 0.1 to 2 % w/v of Trigonella foenum graecum; 0.1 to 2 % w/v of Garcinia cambogia; and 0.01 to 0.5 % w/v of Zingiber officinale to obtain the extract of fenugreek , garcinia and ginger;
d) adding 10 to 20 % w/v of an Emblica officinalis swaras to the extract obtained from step b) and c) to form a mixture; and
e) mixing 0.5 to 4 % w/v of a pharmaceutical excipient with the mixture of step d) under condition to obtain a herbal composition.
9. The method as claimed in claim 8, wherein the solvent is water.
10. The method as claimed in claim 8, wherein the decoction is carried out at a temperature in the range of 70 to 80 °C.
11. The method as claimed in claim 8, wherein the mixing of step e) is carried out at a temperature in the range of 20 to 35 °C until the mixture is homogenously mixed.