|Year : 2022 | Volume
| Issue : 1 | Page : 27-33
Evaluating the Efficacy of Nagarmotha (Cyperus rotundus Linn.) Churna in the Management of Obesity in Comparison with Garcinia cambogia Extract: A Randomized Controlled Open-Label Clinical Trial
Shikha Chaudhary, Rama Kant Yadava, Divya Kajaria
Department of Kayachikitsa, All India Institute of Ayurveda, New Delhi, India
|Date of Submission||29-Nov-2021|
|Date of Decision||14-Mar-2022|
|Date of Acceptance||14-Mar-2022|
|Date of Web Publication||15-Sep-2022|
Department of Kayachikitsa, All India Institute of Ayurveda, New Delhi
Source of Support: None, Conflict of Interest: None
Introduction: Obesity is considered a major public health problem because of its increasing prevalence and risk of other secondary chronic diseases such as cardiovascular disease, musculoskeletal disorders to name a few. Several drugs exist for managing obesity, but they are of passable fleeting effects and in some instances have raised safety concerns too. In addition, dietary supplements have been postulated to promote weight reduction. The best-known fad among many is believed to be Garcinia cambogia to date. Although it is widely used in Asia and Africa, still the use of Garcinia extract remains controversial. Hence, it is imperative to look for new and safer ways to treat obesity. Methodology: The present study was an open labeled randomized clinical study for a duration of 90 days, conducted at All India Institute of Ayurveda, New Delhi. Patients with body mass index >30 to 40 from both gender and age ranging from 20 to 45 years old were included in the study. The intervention for the trial group was Nagarmotha churna (powder of Cyperus rotundus Linn.) which was given orally for three months. Results: The trial group has shown significantly higher weight loss in comparison to Garcinia extract (4.8 vs. 3.02, t value = 4.2, P < 0.05) in the present study. Furthermore, no adverse effects of any intervention were reported in the period of trial. Conclusion: It is concluded that treatment with Nagarmotha churna and G. cambogia extract is useful in reducing weight. However, the trial herb is more well tolerated, safe, and effective for weight management in obese persons as substantiating the fact that the herb used in its classical form have a better result over that of extract used.
Keywords: Ayurveda, garcinia extract, Nagarmotha Churna, obesity, Sthaulya
|How to cite this article:|
Chaudhary S, Yadava RK, Kajaria D. Evaluating the Efficacy of Nagarmotha (Cyperus rotundus Linn.) Churna in the Management of Obesity in Comparison with Garcinia cambogia Extract: A Randomized Controlled Open-Label Clinical Trial. AYUHOM 2022;9:27-33
|How to cite this URL:|
Chaudhary S, Yadava RK, Kajaria D. Evaluating the Efficacy of Nagarmotha (Cyperus rotundus Linn.) Churna in the Management of Obesity in Comparison with Garcinia cambogia Extract: A Randomized Controlled Open-Label Clinical Trial. AYUHOM [serial online] 2022 [cited 2022 Oct 7];9:27-33. Available from: http://www.ayuhom.com/text.asp?2022/9/1/27/356170
| Introduction|| |
Obesity vis-a-vis Sthaulya described as one of the disgraceful disease in Ayurveda which is not merely a cosmetic problem but a severe threat to health in long run. In the present modern era, number of overweight and obese individuals are on exponential rise. The fundamental cause is an energy imbalance between calories consumption and expenditure in today's so-called Obesogenic environment [Table 1].
It is widely regarded as a pandemic with potentially disastrous consequences for human health which may lead to adverse metabolic effects on insulin, cholesterol, triglycerides, and blood pressure. The World Health Organization (WHO) now considers Obesity to be a global epidemic and acknowledges that Obesity is a worldwide problem. According to WHO World Health Statistics Report 2012, globally, one in six adults is obese and nearly 2–8 million individuals die each year due to overweight or obesity and the prevalence of obesity has increased threefold in the last 20 years and continuing to rise. The increasing prevalence of medically significant obesity raises great concern.
In Ayurveda, Sthaulya is described as health condition with laxity and mobility in either or all of buttocks, breasts, and abdomen due to excess of fat which is caused by the vitiation of Medovaha srotas after nidaan sevan, i.e., physical inactivity, day-sleep, excessive intake of heavy diets or diets having high caloric value.
Although the health risks of obesity are largely reversible but still, it is a major problem for many to lose weight which imparts more psychological upset than physical. A wide variety of weight management strategies are currently available, and some involve the use of dietary supplements marketed as slimming aids. Also, many polyherbal ayurvedic interventions have been used in managing obesity but randomized clinical study on single herb preparation in the Ayurvedic field has not been reported till date. In the recent past, Garcinia cambogia is very commonly used in obesity across India and overseas too as a table top drug without any medical advice and has been marketed as slimming aid. Some studies also showed G. cambogia has no effect in weight loss and instead poses adverse effects (see addendum). However, there is no comparative clinical study has been reported till date using ayurvedic treatment in comparison with G. cambogia in the management of obesity.
The idea of using single herb preparation in this study is to know the efficacy of the proposed medicine precisely on the principles based on panchmahabhuta and tridosha. The proposed herb, i.e., Nagarmotha churna is the foremost in lekhaniya mahakashaya i.e., group of herbs mentioned for weight reduction. Many in vitro, in vivo, and clinical trial, has shown the pharmacological mechanisms of Cyperus rotundus and indicate the various medicinal properties, for example, anti-hyperlipidemic, hepatoprotective, gastroprotective, anti-obesity, anti-oxidant properties are due to the presence of various phytochemicals.,
In addition, previous experimental study stated that administration of aqueous tuber extract of C. rotundus L. (ATECR) did not alter food intake in treated rats, indicating that the prevention of weight gain induced by C. rotundus extract was not due to a reduction of energy intake. ATECR might have increased the catabolism of lipids in adipose tissue resulting in a decrease in mean body weight.
Objective of the study
To determine the comparative efficacy of Nagarmotha (C. rotundus Linn.) churna over that of G. cambogia extract in the management of Obesity.
| Methodology|| |
After blood investigation, once the patient qualified to be included in the study based on criteria was randomly allocated to one of the two groups (based on [Chart 1]). The research methodology has been described in [Table 2] for study and the set of measurements were applied presented in [Table 3] which ensured the selection of homogeneous group to reduce the variability. Patients were advised to visit the hospital from zero day to on 15th, 30th, 60th, and 90th days with window period of 7 days. The interventions have been used in the study along with the posology depicted in [Table 4]. The graphic presentation of the study design is depicted in [Chart 2].
- Patients of either gender with age between 20 and 45 years
- Willing and able to participate in the study for 3 months.
- Intake of over-the-counter weight loss agents, centrally acting appetite suppressants in the previous six months or underwent any surgical therapy
- Pathophysiologic/genetic syndromes associated with obesity (Cushing's syndrome, Turner's syndrome, Prader-Willi syndrome)
- Patients with poorly controlled Hypertension (>160/100 mm Hg)
- Patients on prolonged (>6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc., or any other drugs that may have an influence on the outcome of the study
- Alcoholics or drug abusers and pregnant/lactating woman.
Ethical approval and CTRI registration
Ethical approval was taken from the Institutional Ethics Committee (IEC No.: AIIA/2017/PG-18). Afterward, the study has been registered in CTRI (Registration No.:-CTRI/2017/11/010519).
Parameters for assessment of study outcomes
Primary Endpoint: Weight loss.
- Changes in body mass index (BMI)
- Changes in waist circumference and Waist-hip ratio (WHR)
- Changes in Serum Triglyceride and Cholesterol level.
- Lost to follow-up
- Discontinued due to personal reason
- Any adverse effects of any intervention.
Statistical tool and method
The research data were analyzed using GraphPad prism V. 8.1.1 (224) software and student “t”-test; test of significance was used to compare proportions.
| Observations and Results|| |
In the present clinical study, a total of 68 patients were registered irrespective of their sex, religion, caste, ethnicity, and nationality in the age group of 20–45 years; demographic characteristic of patients is presented in [Table 5]. The registered patients were randomly divided into two groups viz. trial group (Nagarmotha churna) and control group (G. cambogia extract). Out of 68, 56 patients completed the course of the interventions. A total of 12 patients were turned down in the study.
Moderate reductions in weight and BMI from pre- to post-measures were Demonstrated and Slight reduction in WHR was also demonstrated [Table 6]. There was no statistically significant difference found in biochemical parameters except mean reduction in hemoglobin by 0.34 in Group B and mean reduction in Alkaline phosphatase by 7.8 in Group A which found to be statistically significant too. However, this difference was within the normal limit of the concerned hematological parameter before and after the treatment. This difference might be due to some factors which have no clinical significance as such in this study.
| Discussion|| |
The fundamentals of Ayurvedic drug action are scientific and based on five mechanisms action, namely, of Rasa (taste appreciation on the tongue), Guna (properties of any herb), Veerya (potency of herb), Vipaka (intestinal digestion and tissue metabolism) and Prabhava (specific action through specialized receptors). All these actions are biophysical in nature.
The Nagarmotha possess katu (pungent), tikta (bitter) and kashaya (astringent) as predominant rasa. Kashaya rasa has ruksha (rough) and laghu (light in nature) properties along with samshamana, shoshana, shelshma-rakta-pitta prashamana, kleda-shoshana effects. Tiktarasa by its laghu, ruksha properties; helps in kaphashamana. Tiktarasa having lekhana, meda-vasa-shleshma upashoshana properties indicate its medohara effect and katurasa has meda-sneha-kleda shoshana karma.
The main pathological factor in Sthaulya is kapha and meda both are of snigdha (unctuous) guna; jala and prithvi mahabhuta while trial drug is agni, vayu and akash mahabhuta dominant because of its katu, tikta rasa and rukshaguna. Panchabhautik constituents of kapha and meda (Snigdha, Guru guna) verses Nagarmotha churna (Ruksha, Laghu guna) are just opposite. Hence, the trial drug was effective by the virtue of it dosha and vyadhi-vipreeta properties (antagonise the pathogenesis of the disease).
Acharya Sushruta has mentioned rasa as the fundamental cause in the pathology of Sthaulya. Improper rasa dhatu leads to the production of Ama (vitiated metabolic products) in the body. The property of Nagarmotha churna is agni-deepana (improve digestive and metabolic activity) as well as pachana (digest the unwanted metabolic bi-product) too. Hence, it will dissociate the basic underlying pathology, i.e., deduction of ama. Simultaneously, by the virtue of its properties, namely, laghu, ruksha, lekhaneeya; the drug will remove the sanga in srotas (obstruction in channels of the body). Eventually, it will lead to the proper function of medovaha srotas. Overall, the action of the drug is holistic in nature, i.e., correcting all the disease-causing pathological factors without having any noticeable adverse effects.
Experimental study on C. rotundus preparations (powder in fine suspension, aqueous and alcoholic extracts) was found to have lipolytic action and mobilized fat from the adipose tissues in rats, thus helping to reduce obesity. It was also demonstrated that administration of 45 or 220 mg/kg/day of its tubers hexane extract for 60 days in Zucker rats induced a significant reduction in weight gain without affecting food consumption or inducing toxicity. In vitro, this extract was able to stimulate lipolysis in 3T3-F442 adipocytes suggesting that this medicinal plant contains activators of adrenoreceptors (AR). The binding assay performed on the rat β3-AR isoform, known to induce thermogenesis, demonstrated that tubers extract can consistently and effectively bind to this receptor. These data suggest that the effect on weight gain exerted by tubers extract may be mediated, at least partially, through the activation of the 3-AR. A pilot study carried out on 30 obese people who were administered the powdered tuber of C. rotundus for 90 days, showed reduction in weight along with a decrease in serum cholesterol and triglycerides.
Based on the classical texts references, G. cambogia is in use as a source of Vrikshamla with approval from the AYUSH department. Although Garcinia indica has been mentioned as source of Vrikshamla, the commercially viable material is G. cambogia only. The advantage of using G. cambogia is that it has significantly high “hydroxycitric acid (HCA)” content in comparison to Garcinia indica.
The peel of the fruit contains high amounts of HCA, which is the active ingredient believed to be responsible for most of its weight loss benefits. The study suggested mechanism of action in obesity involves HCA-inhibiting lipogenesis, increase in lipid oxidation, and reduction of food intake., HCA competitively inhibits adenosine triphosphate-citrate (pro-3S)-lyase, an extra-mitochondrial enzyme that plays a role in fatty acid biosynthesis.
The churna being used here is nothing but the classical form of herb i.e., powder of tuber of C. rotundus. First, using herbs in classically prescribed form is a common practice in Ayurveda since Vedic period without any noticeable side effects and their use has stood the test of time. Herbs provide treatment of diseases in a holistic approach based on Ayurvedic concept of Panchamahabhutas and Tridoshas. Herbs in its classical form might be bio-available often because of the presence of many other compounds that aid absorption which may act agonistic for maintenance of normal physiological functions and antagonistic to the vitiated doshas (body humors of the body) and dushyas (morbid tissues) where it arrests the pathology as therapeutic effect of herbs are exerted due to the presence of different phytoconstituents which work holistically. Extracted herbal compounds often lack this bioavailability. Hence, while the concentration of the supposed active compound may be quite high, the amount entering might be small which does not provide the expected required outcome and might cause adverse effects.
| Conclusion|| |
The mean reduction of weight in the patients of obesity (n = 29) was 4.80 who were treated with Nagarmotha churna, when compared to G. cambogia extract (n = 27) in which the mean reduction of weight was 3.03, which showed a statistically significant difference. It hence substantiates the hypothesis that the single drug preparation of Nagarmotha churna is more efficacious in the management of obesity in comparison to Garcinia extract without any noticeable side effects.
Limitations of the study
- Large sample size may help to prove its efficacy with extensive data
- Follow-up may add to efficacy measures.
Some studies conclude that G. cambogia has no weight loss effect and also suggest its liver toxicity.,,,, However, a recent search of FDA's adverse events surveillance database for “Hydroxycut,” “hydroxycitric acid,” “G. cambogia,” or “Super Citrimax” (the proprietary blend of G. cambogia used in Hydroxycut) yielded no reports in this regard and no adverse effects have been noticed in the present study too. In the past few years, publications are alerting the public to its forthcoming determination that dietary supplements containing G. cambogia present an unreasonable risk of illness or injury, and should not be consumed. Although products marketed as dietary supplements using G.cambogia like the one tested herein will presumably be good to consume and these results might still be of value to those in parts of the world where this slimming aid may still be in use, to researchers considering designing studies of other dietary supplements for weight loss, to litigators working on cases involving alleged effects of G. Cambogia containing products, and to manufacturers of new potential anti-obesity products who wish to consider the effects of related products.
Financial support and sponsorship
All India Institute of Ayurveda, New Delhi.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]