Clinical Safety and Efficacy of Ayurveda Multi-Herbal Formulation in the Management of Obesity

Abstract

Background

Obesity is a medical condition characterized by the excessive accumulation of body fat, which adversely impacts health. It is primarily caused by a combination of overeating, physical inactivity, and genetic predisposition. In Ayurveda, obesity corresponds to conditions such as Sthaulya and Medoroga. Ayurvedic formulations like Vyoshadi Guggulu (VSG) and Vidanga Churna (VDC) are commonly prescribed for managing obesity despite limited scientific validation. This study aimed to evaluate the safety and efficacy of VSG and VDC in individuals with obesity.

Methods

A prospective, open-label, multicenter clinical study was conducted at 2 peripheral centres of the Central Council for Research in Ayurvedic Sciences (CCRAS). A total of 100 obese patients who met the selection criteria were recruited from outpatient departments and administered VSG (1 gm thrice daily after meals with lukewarm water) and VDC (3 gm twice daily after meals) for 12 weeks. Participants were followed up for an additional 2 weeks without medication.

Results

Statistically significant improvements were observed in key symptoms, including polyphagia, polydipsia, excessive sweating, excessive sleep, body fatigue, and dyspnea on exertion (DOE), which was initially reported by 36 participants but reduced markedly over the study period. While most participants had moderate physical activity capacity (Vyayama Shakti), some experienced exertional breathlessness, which improved with intervention. Significant reductions were also noted in BMI (P = 0.016), waist circumference (P = 0.043), and serum cholesterol levels (P = 0.002), with no adverse drug reactions reported.

Conclusion

This study demonstrates that the combination of VSG and VDC is effective and safe for managing obesity. Statistically significant improvements in anthropometric parameters and clinical symptoms highlight the potential of these Ayurvedic formulations as complementary therapies for obesity management.

Introduction

Obesity is a rapidly growing public health concern in India, with recent studies indicating that over 135 million individuals are affected. The ICMR-INDIAB study (2015) estimates that the prevalence of abdominal obesity ranges from 16.9% to 36.3% across different regions, with urban populations being more significantly affected. ¹ The increasing incidence of obesity has been linked to lifestyle transitions, including sedentary habits, processed food consumption, and economic shifts that favour fast-paced, less nutritious dietary choices. Beyond its medical implications, obesity also carries social and psychological consequences, such as stigma, decreased productivity, and financial strain due to associated health complications.^2,3 Given these challenges, traditional Ayurvedic approaches to weight management have gained renewed interest, particularly due to their holistic focus on metabolic balance, dietary regulation, and individualized treatment strategies. This study aims to evaluate the safety and efficacy of an Ayurvedic multi-herbal formulation in obesity management, offering insights into how traditional medicine can address modern health challenges.

Ayurveda, the ancient Indian system of medicine, provides a unique perspective on obesity. Known as Sthaulya or Medoroga in classical Ayurvedic texts, obesity is described as a metabolic disorder resulting from an imbalance of the 3 doshas—Vata, Pitta, and Kapha (3 elemental humours). Specifically, Kapha dosha and Meda dhatu (fat tissue) are predominantly aggravated. According to Acharya Charaka, Sthaulya is considered 1 of the undesirable constitutions (Ashtaunindita Purusha), while Acharya Sushruta highlights the chronic ill-health (Sadatura) associated with this condition. ⁴ Ayurvedic principles emphasize that obesity arises from a combination of poor dietary habits, sedentary lifestyles, and impaired digestive fire (Agni), leading to the accumulation of toxins (Ama) and fat deposits in the body. ⁵ The pathogenesis of obesity in Ayurveda revolves around the dysfunction of Medo dhatvagni (metabolic fire regulating fat tissue). The imbalance results in impaired lipid metabolism, which manifests as an excess of adipose tissue and related systemic dysfunctions. This understanding underscores the importance of addressing the root causes through a combination of lifestyle modifications, dietary interventions, and herbal formulations. ⁶

Vyoshadi Guggulu (VSG) and Vidanga Churna (VDC) are 2 widely used Ayurvedic formulations for managing obesity. VSG is a polyherbal preparation with ingredients such as Guggulu (Commiphora mukul), Shunthi (Zingiber officinale), and Haritaki (Terminalia chebula), which are known for their Lekhaniya (emaciating), Kapha-pacifying, and metabolic-enhancing properties. ⁷ Similarly, VDC, primarily composed of Vidanga (Embelia ribes), is renowned for its lipid-lowering and anti-obesity effects. ⁸ These formulations are believed to enhance Agni, reduce Ama, and mobilize stored fat by improving lipid metabolism. ⁹

Modern pharmacological studies have highlighted the potential of the ingredients in VSG and VDC. Vidanga has demonstrated lipid-lowering effects, anti-adipogenic properties, and antioxidant potential in preclinical studies. ¹⁰ For example, embelin, the active compound in Vidanga, has shown significant reductions in cholesterol and triglyceride levels in animal models, along with improvements in insulin sensitivity. ¹¹ Similarly, Guggulu has been extensively studied for its lipid-lowering properties, anti-inflammatory effects, and role in enhancing metabolic functions. ¹² Clinical trials on Guggulu formulations have shown improvements in BMI and waist circumference in individuals with obesity. ¹³ However, most existing studies are either preclinical or conducted on individual ingredients rather than standardized formulations. Furthermore, they often lack comprehensive assessments of safety and efficacy in a clinical setting, particularly in the context of combined Ayurvedic interventions like VSG and VDC. ¹⁴

The present study evaluates the combined use of VSG and VDC, leveraging their synergistic effects in a clinically controlled, multicenter environment. Unlike previous studies, which often focus on isolated ingredients or lack rigorous clinical methodologies, this study integrates traditional Ayurvedic knowledge with modern clinical practices. Assessing multiple parameters—including BMI, waist circumference, lipid profile, and quality-of-life metrics—provides a holistic evaluation of these formulations. Additionally, safety assessments, such as liver and kidney function tests, address gaps in prior research by ensuring the formulations are effective and safe for prolonged use.^15,16

The Ayurvedic evaluation of participants was also conducted by trained Ayurvedic physicians using a standardized Prakriti assessment questionnaire based on classical Ayurvedic texts and validated methodologies. The assessment included an evaluation of the participants’ dominant dosha (Vata, Pitta, Kapha), Agni (digestive fire), Meda Dhatu (fat tissue metabolism), and Vyayama Shakti (physical endurance). Clinicians utilized a combination of structured interviews, observational analysis, and pulse diagnosis (Nadi Pariksha) to determine individual constitutional characteristics. Additionally, participants’ dietary habits (Ahara Shakti) and adaptation to different food types (Satmya) were assessed based on Ayurvedic principles. These factors were used to tailor the interpretation of obesity in the Ayurvedic framework, ensuring a more individualized approach to the intervention. Overall, this study represents a significant step toward validating Ayurvedic treatments for obesity, offering robust evidence for their integration into contemporary healthcare practices.

Materials and Methods

Study Design and Setting

The study was a prospective, multicentre, open-label, single-arm clinical study. It was conducted at 2 institutes of the Central Council for Research in Ayurvedic Sciences (CCRAS), Viz, Central Ayurveda Research Institute (CARI), Bengaluru and M.S. Regional Ayurveda Research Institute (M.S. RARI), Jaipur. Participants attending the OPD facilities of the study sites and fulfilling the selection criteria were recruited for participation in the study.

Ethical Consideration

The study protocol was approved by the Institutional Ethics Committees of both study centres (CARI Bengaluru: F.6-5/RARIMD/BNG/IEC Meet/2020-21, dated 26.09.2020; RARI Jaipur: F.5/Lab/Pre-iron/Ethics/2007-08/CRAI-JPR, dated 04.07.2020). Written informed consent was obtained from all participants after providing them with comprehensive details about the study. The study was conducted following Good Clinical Practice (GCP) guidelines and the Ethical Guidelines for Biomedical Research on Human Participants (ICMR, 2017). The trial was registered with the Clinical Trials Registry of India (CTRI/2022/05/042681).

Inclusion Criteria

Participants who were included in the study were adult males and females aged between 18 and 45 years. They had a Body Mass Index (BMI) ranging from 25 to 39.9 kg/m², which classifies them as overweight or obese according to standard BMI categories. Additionally, eligible participants were required to demonstrate a clear willingness to adhere to the study protocol, including compliance with scheduled visits, medication intake, and other study requirements. This ensured that only those who were motivated and capable of following the rigorous study regimen were enrolled.

Exclusion Criteria

Participants were excluded from the study if they exhibited any of the following conditions or circumstances: Obesity due to secondary causes, such as hypothyroidism, PCOD, or Cushing’s syndrome; poorly controlled hypertension (BP >160/100 mm Hg); uncontrolled diabetes mellitus (HbA1c >8%); use of medications that could influence study outcomes, including corticosteroids, antipsychotics, or immunosuppressants; significant systemic illnesses, such as rheumatoid arthritis, tuberculosis, or inflammatory bowel disease; recent cardiac events or severe cardiac conditions, such as myocardial infarction or stroke, within the past 6 months; concurrent serious hepatic, renal, or pulmonary disorders; pregnancy, lactation, or plans for conception during the study period; known hypersensitivity to the trial drugs or their ingredients; or any condition deemed unsuitable by the investigator.

Interventions

The intervention includes 2 Ayurvedic formulations prescribed based on classical references and standard pharmacopoeial guidelines. The first intervention, Vidanga Churna (VDC), is a powdered formulation prepared according to the Ayurvedic Pharmacopoeia of India (API, Part-I, Vol.-II). It is administered orally in a dose of 3 grams twice daily after food. Vidanga (Embelia ribes) is traditionally known for its antiparasitic, digestive, and metabolic-enhancing properties. The second intervention, Vyoshadi Guggulu (VSG), is a polyherbal tablet formulation standardized as per the Ayurvedic Formulary of India (AFI - Part-I, 5:9; API, Part-II, Vol.-II). Each dose comprises 2 tablets (500 mg each), totalling 1 gram, taken thrice daily after food. Vyoshadi Guggulu is recognized for its anti-inflammatory, lipid-lowering, and rejuvenating properties, often used in managing obesity, joint disorders, and metabolic imbalances. The routes of administration and timing aim to optimize therapeutic outcomes by aligning with digestive and metabolic rhythms post-meal.

Outcome Measurements

The primary outcomes of the study were to assess changes in Body Mass Index (BMI), waist circumference, mean body weight from baseline, and the proportion of participants achieving a minimum of 10% weight loss. The secondary outcomes included the assessment of changes in body fat percentage using Dual-Energy X-ray Absorptiometry (DEXA) scans, ¹⁷ the effects of the intervention on Obesity and Weight Loss Quality of Life (OWL-QoL) scores, ¹⁸ alterations in lipid profiles, and changes in glycated haemoglobin (HbA1c) levels. ¹⁹

Safety Assessment

The safety of the selected interventions was evaluated by analyzing their impact on the parameters of Liver Function Tests (LFT) and Kidney Function Tests (KFT). Additionally, any adverse events (AEs) reported by participants were documented using a standardized AE reporting format. The recorded details included the participant’s name, the nature of the adverse event, date of onset, severity, relationship to the intervention, and the treatment administered.

Study Timeline

The study was conducted in distinct phases. During the screening phase, informed consent was obtained, eligibility was assessed based on inclusion and exclusion criteria, and laboratory investigations were performed. At the baseline visit, personal and demographic data were collected, clinical examinations and assessments of Ayurvedic parameters were performed, and body weight, BMI, waist circumference, and DEXA scans were recorded. Participants were provided with the study drugs and compliance report forms, with instructions to return after 2 weeks. During the treatment period, follow-up visits were conducted on days 14, 28, 42, 56, and 70, during which drug compliance, clinical assessments, Ayurvedic parameter evaluations, and measurements of body weight, BMI, and waist circumference were monitored. Study drugs and updated compliance forms were issued at each visit. At the end of the 12-week treatment period (day 84), all baseline assessments were repeated, including a DEXA scan, laboratory investigations, and the Obesity and Weight Loss Quality of Life (OWL-QoL) questionnaire, with participants advised to return for a follow-up visit in 2 weeks. The final follow-up visit on day 98 included clinical examinations, Ayurvedic parameter assessments, and measurements of body weight, BMI, and waist circumference, alongside OWL-QoL data collection, ensuring a comprehensive evaluation of the interventions’ effects (Figure-1).

Figure 1.

Study Schedule and Timeline

Data Collection and Management

Data for this study were documented using both specifically designed Case Report Forms (CRFs) and electronic Case Report Forms (e-CRFs) in compliance with Good Clinical Practice (GCP) guidelines. Data management procedures included the completion of source documents at the time of data collection, which were subsequently transcribed into the CRFs and e-CRFs. All source documents were securely stored at the study sites to facilitate review by monitoring teams, auditing personnel, or ethics committees, as required by regulatory guidelines. Access to the data was restricted to research personnel with delegated responsibilities from the Principal Investigator and to the statistician for the purpose of data analysis.

Sample Size Determination

The sample size was calculated based on the assumption of a mean reduction in BMI of 2 kg/m² following treatment, with a standard deviation of 4.5 kg/m² derived from previous studies. Using a 95% confidence level and a study power of 80%, the required sample size was determined to be 40 participants. Accounting for an anticipated dropout rate of 20%, the final target sample size was adjusted to 50 participants per centre. The study was conducted across 2 centres, with a total of 50 participants recruited at each centre, resulting in a final sample size of 100 participants for the study.

Statistical Analysis

Following data collection, verification was performed to ensure accuracy and adherence to predefined limits. The cleaned and validated data were used for further analysis and interpretation. Categorical variables were summarized as frequencies and percentages, while continuous variables with a normal distribution were expressed as mean ± standard deviation (SD). Continuous variables without a normal distribution were reported as median (Q1, Q3). Pre-post comparisons of continuous variables were analyzed using either the paired t-test or the Wilcoxon signed-rank test, depending on the data distribution. For assessment parameters measured at more than 2 follow-ups, repeated measures analysis of variance (r-ANOVA), Friedman test, or Cochran’s Q test was employed to identify statistically significant differences across follow-ups. A 5% level of significance (P < 0.05) was applied for all statistical tests. Data analysis was conducted using SPSS software version 26.0.

Observation and Results

Number of Participants

During the recruitment phase at MSRARI, 67 participants were screened, of whom 17 did not meet the eligibility criteria and were excluded. Of the 50 participants enrolled, 37 completed the study, while 13 dropped out. At CARI, all 50 screened participants met the eligibility criteria and were enrolled. Among these, 49 participants completed the study, with only 1 dropout. In total, 117 participants were screened across both centres, with 17 screen failures. Out of the 100 participants enrolled, 86 completed the study, resulting in an overall dropout rate of 14%. These details are illustrated in Figure 2.

Figure 2.

Outflow of the Study Participants

Baseline Characteristics

The baseline characteristics of the study participants are summarized in Figure 3. The mean age of the participants was 34.07 ± 6.324 years. A majority of participants were female (n = 56, 64.1%), while 30 (34.9%) were male. Most participants were married (n = 73, 84.9%), with 13 (15.1%) being unmarried.

Figure 3.

Baseline Characteristics of the Participants

In terms of educational qualifications, 1 participant (1.2%) was illiterate, 6 (7.0%) had completed primary school, 5 (5.8%) had a middle school certificate, 10 (11.6%) had completed high school, 19 (22.1%) had an intermediate or diploma qualification, 36 (41.9%) were graduates, and 9 (10.5%) held a professional or honors degree.

Regarding occupation, 38 participants (44.2%) were engaged in desk work, 4 (4.7%) performed fieldwork involving physical labour, 9 (10.5%) did fieldwork without physical labour, and 34 (39.5%) were housewives. Data on occupation were missing for 1 participant (1.2%).

Socioeconomic status revealed that 2 participants (2.3%) belonged to the upper class, 37 (43.0%) to the upper middle class, 39 (45.3%) to the lower middle class, 5 (5.8%) to the upper lower class, and 3 (3.5%) to the lower class.

The majority of participants resided in urban areas (n = 83, 96.5%), with only 3 participants (3.5%) from rural areas. In terms of religion, 85 participants (98.8%) identified as Hindu, and 1 (1.2%) identified as Muslim.

Clinical history indicated that 17 participants (19.8%) had an acute onset of symptoms, while 51 (59.3%) had an insidious onset. A history of past illness was reported by 8 participants (9.3%), whereas 59 participants (68.6%) reported no history of past illness.

Personal History

The personal history of the study participants is summarized in Figure 4. Dietary habits revealed that 47 participants (54.7%) were vegetarians, while 39 participants (45.3%) were non-vegetarians. Regarding substance use, the majority (n = 77, 89.5%) reported no addictions. Among the remaining participants, 3 (3.5%) were smokers, 2 (2.3%) used tobacco, 3 (3.5%) consumed alcohol, and 1 (1.2%) reported drug use. Smoking patterns showed that 2 participants (2.3%) were regular smokers, 2 (2.3%) smoked occasionally, and 81 (94.2%) had never smoked.

Figure 4.

Personal History of the Participants

Physical activity levels were reported as adequate by 15 participants (17.4%), while 71 participants (82.6%) had inadequate physical activity. Allergies were reported by 9 participants (10.5%), whereas 77 participants (89.5%) denied any allergies. Medication use was reported by 3 participants (3.5%), while 83 participants (96.5%) were not on any medications during the study period.

Caloric intake data showed that 42 participants (48.8%) adhered to a 1200 kcal/day diet, 11 participants (12.8%) followed a 1400 kcal/day diet, 17 participants (19.8%) consumed 1600 kcal/day, and 16 participants (18.6%) followed an 1800 kcal/day diet.

Ayurvedic Parameters

The study also examined the participants’ Ayurvedic characteristics, which include aspects of their body constitution (Prakruti) and other traits based on traditional Ayurvedic principles (Figure 5). The assessment of Saara (tissue strength), Satmya (dietary adaptability), and Satva (mental strength) was conducted using validated Ayurvedic clinical scales based on classical Ayurvedic texts and standardized research methodologies. Trained Ayurvedic physicians evaluated these parameters through structured Prakriti and Dhatu Saara assessment tools, incorporating both qualitative and semi-quantitative grading systems.

Figure 5.

Ayurvedic Parameters of the Study Participants

Saara was assessed using the Ashta Saara Pareeksha method described in classical texts, categorizing individuals into Pravara (excellent), Madhyama (moderate), and Avara (low) based on tactile examination of skin texture, muscle tone, hair quality, and other bodily characteristics. The evaluation was conducted using a validated Saara assessment questionnaire, commonly employed in Ayurvedic research.

Satmya, which refers to dietary adaptability, was classified into Pravara, Madhyama, and Avara based on participants’ self-reported ability to tolerate and digest different food types, including grains, dairy, and other dietary components. This was assessed using a structured Satmya evaluation questionnaire, considering long-term dietary habits and digestive responses.

Satva, which indicates mental resilience, was evaluated using a Satva Pareeksha questionnaire, categorizing individuals into Pravara (high resilience), Madhyama (moderate resilience), and Avara (low resilience) based on psychological traits such as stress tolerance, emotional stability, decision-making ability, and response to challenges. All assessments were conducted by experienced Ayurvedic physicians and cross-verified for consistency, ensuring reliability in determining Ayurvedic constitutional characteristics relevant to obesity management.

Constitution (Prakruti)

Prakruti refers to the basic physical and mental constitution of an individual, which is determined at birth. Most participants had a combination constitution, with 34.9% having a Pitta-Kaphaja Prakruti (a mix of qualities associated with metabolism and structure) and 31.4% having a Vata-Kaphaja Prakruti (a mix of movement and structure). Pure constitutions were less common: 1.2% had Vataja Prakruti (movement-related qualities), 9.3% had Pittaja Prakruti (metabolism-related qualities), and 7.0% had Kaphaja Prakruti (structure-related qualities).

Tissue Strength (Saara)

Saara describes the quality of different body tissues. Most participants (41.9%) had well-developed fat tissue (Meda Saara), which aligns with the condition of obesity. Other common tissue types included Mamsa Saara (31.4%, related to muscles) and Rakta Saara (22.1%, related to blood). Very few had strong qualities of skin or bones (Rasa/Twaka Saara and Asthi Saara).

Diet Compatibility (Satmya)

Satmya indicates how well a person’s body adapts to different diets and environments. Most participants (77.9%) had a medium level of adaptability (Madhyama Satmya), meaning they can handle a balanced diet. A smaller percentage had excellent adaptability (Pravara Satmya, 15.1%), while 7.0% had poor adaptability (Avara Satmya).

Mental Strength (Satva)

Satva represents mental and emotional strength. Most participants (73.3%) had moderate mental resilience (Madhyama Satva), while 26.7% had high resilience (Pravara Satva). None of the participants exhibited low mental strength (Avara Satva).

Digestive Strength (Ahara Shakti)

Ahara Shakti refers to the capacity to digest food. Most participants (90.7%) had moderate digestive strength (Madhyama Ahara Shakti), while a few had excellent or poor digestive abilities (Pravara, 4.7%, and Avara, 4.7%).

Physical Activity Capacity (Vyayama Shakti)

Vyayama Shakti indicates the ability to perform physical work or exercise. Most participants (81.4%) had moderate physical stamina (Madhyama Vyayama Shakti), while 18.6% had high stamina (Pravara Vyayama Shakti). None of the participants showed poor physical strength (Avara Vyayama Shakti).

The majority of participants in this study had moderate adaptability to food, moderate mental and physical strength, and moderate digestive capacity. These traits reflect a balanced but not extreme constitution. Most participants also showed characteristics that align with a higher tendency toward obesity (Meda Saara), which supports the need for targeted interventions in this population. Understanding these Ayurvedic characteristics helps in designing personalized treatment plans.

Effect of Treatment on Chief Complaints

The effect of treatment on the chief complaints of participants was monitored over a 98-day period at eight-time points: baseline, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day, and 98th day.

At baseline, polyphagia was reported by 24 participants (27.9%), which progressively declined to 3 participants (3.5%) by day 98. This reduction was statistically significant, with a P-value of <0.001. Polydipsia was initially reported by 32 participants (37.2%). Although the prevalence fluctuated slightly, it decreased to 20 participants (23.3%) by day 98, with a statistically significant P-value of <0.001.

At baseline, excess sweating was reported by 26 participants (30.2%). By the end of the study, this number had decreased to 11 participants (12.8%), demonstrating a significant reduction (P < 0.001). Similarly, excess sleep was reported by 29 participants (33.7%) at baseline, reducing significantly to 6 participants (7.0%) by day 98 (P < 0.001).

Body fatigue was reported by 63 participants (73.3%) at baseline, but this complaint declined significantly to 16 participants (18.6%) by day 98, with a P-value of <0.001. Conversely, loss of libido, reported by 6 participants (7.0%) at baseline, showed minor variation throughout the study and ended with 3 participants (3.5%) by day 98. However, this change was not statistically significant (P = 0.229).

Palpitation and/or dyspnoea on exertion was reported by 36 participants (41.9%) at baseline, and the prevalence decreased significantly to 7 participants (8.1%) by day 98 (P < 0.001).

These findings demonstrate significant improvements in most of the monitored complaints over the course of the study, as detailed in Table 1.

Table 1.

Effect of Treatment on Chief Complaints

Chief complaint	Baseline	14th day	28th day	42nd day	56th day	70th day	84th day	98th day	P-Value a
Polyphagia	24 (27.9%)	19 (22.1%)	13 (15.1%)	11 (12.8%)	6 (7.0%)	6 (7.0%)	5 (5.8%)	3 (3.5%)	<0.001
Polydipsia	32 (37.2%)	33 (38.4%)	30 (34.9%)	22 (25.6%)	25 (29.1%)	19 (22.1%)	19 (22.1%)	20 (23.3%)	<0.001
Excess sweating	26 (30.2%)	29 (33.7%)	31 (36.0%)	24 (27.9%)	23 (26.7%)	21 (24.4%)	14 (16.3%)	11 (12.8%)	<0.001
Excess sleep	29 (33.7%)	23 (26.7%)	24 (27.9%)	22 (25.6%)	13 (15.1%)	7 (8.1%)	8 (9.3%)	6 (7.0%)	<0.001
Body fatigue	63 (73.3%)	57 (66.3%)	50 (58.1%)	43 (50.0%)	36 (41.9%)	25 (29.1%)	19 (22.1%)	16 (18.6%)	<0.001
Loss of libido	6 (7.0%)	8 (9.3%)	8 (9.3%)	5 (5.8%)	5 (5.8%)	4 (4.7%)	4 (4.7%)	3 (3.5%)	0.229
Palpitation/dyspnoea on exertion	36 (41.9%)	26 (30.2%)	24 (27.9%)	15 (17.4%)	16 (18.6%)	12 (14.0%)	10 (11.6%)	7 (8.1%)	<0.001

^aCalculated through Cochran-Q Test.

Effect of Treatment on Primary Outcome Measures

The effect of treatment on primary outcome measures was assessed over a 98-day period, with data collected at baseline, and on days 14, 28, 42, 56, 70, 84, and 98. The results are summarized in Table 2.

Table 2.

Effect of Treatment on Primary Outcome

Physical examination	Baseline	14th day	28th day	42nd day	56th day	70th day	84th day	98th day	P-Value a
Weight	77.93 ± 11.321	77.20 ± 10.363	77.01 ± 10.293	76.95 ± 10.571	76.80 ± 10.615	76.25 ± 10.791	76.00 ± 10.735	75.83 ± 10.799	0.113
Body mass	29.99 ± 4.392	30.20 ± 3.196	30.13 ± 3.144	30.12 ± 3.225	30.03 ± 3.261	29.85 ± 3.233	29.72 ± 3.238	29.64 ± 3.228	0.016
Waist circumference	100.32 ± 7.810	100.59 ± 10.795	99.40 ± 7.260	97.68 ± 12.964	98.46 ± 7.548	98.10 ± 7.782	98.07 ± 7.375	97.93 ± 7.600	0.043
DEXA scam	47.31 ± 9.666	-----	-----	-----	-----	-----	47.42 ± 8.532	------	0.912
Total score (OWLQOL)	46.98 ± 21.334	-----	-----	-----	-----	-----	54.40 ± 24.319	56.00 ± 24.279	0.186

^aCalculated through rANOVA/paired t-test.

The average body weight decreased from 77.93 ± 11.321 kg at baseline to 75.83 ± 10.799 kg by day 98. However, this reduction was not statistically significant (P = 0.113). The average Body Mass Index (BMI) showed a slight yet statistically significant reduction, declining from 29.99 ± 4.392 at baseline to 29.64 ± 3.228 by day 98 (P = 0.016).

Waist circumference decreased significantly over the study period, from 100.32 ± 7.810 cm at baseline to 97.93 ± 7.600 cm by day 98 (P = 0.043). The DEXA scan values remained largely unchanged, with an average of 47.31 ± 9.666 at baseline and 47.42 ± 8.532 by day 84, showing no statistically significant difference (P = 0.912).

The total score of the Obesity Weight Loss Quality of Life (OWL-QoL) instrument increased from 46.98 ± 21.334 at baseline to 56.00 ± 24.279 by day 98. However, this improvement was not statistically significant (P = 0.186).

Overall, the study demonstrated significant reductions in BMI and waist circumference but did not observe statistically significant changes in body weight, DEXA scan results, or OWL-QoL scores during the study period (Table 2).

Physical Examinations

The findings from physical examinations conducted at baseline and various intervals up to the 98th day are presented in Table 3.

Table 3.

Physical Examination of the Study Participants

Physical examination	Baseline	14th day	28th day	42nd day	56th day	70th day	84th day	98th day
Sleep	70 (81.4%)	85 (98.8%)	84 (97.7%)	84 (97.7%)	86 (100.0%)	85 (98.8%)	84 (97.7%)	84 (97.7%)
Appetite	70 (81.4%)	80 (93.0%)	83 (96.5%)	83 (96.5%)	85 (98.8%)	83 (96.5%)	86 (100.0%)	85 (97.7%)
Bowel habits	77 (89.55%)	85 (98.8%)	86 (100.0%)	84 (97.7%)	86 (100.0%)	86 (100.0%)	85 (98.8%)	84 (97.7%)
Stool consistency	73 (84.9%)	82 (95.3%)	84 (97.7%)	85 (98.8%)	85 (98.8%)	86 (100.0%)	86 (100.0%)	82 (95.3%)
Urine output	80 (93.0%)	83 (96.5%)	85 (97.7%)	86 (100.0%)	84 (97.7%)	84 (97.7%)	86 (100.0%)	84 (97.7%)
Oral temperature	97.40 ± 2.186	97.63 ± 0.754	97.64 ± 0.761	97.65 ± 0.769	97.64 ± 0.769	97.38 ± 2.173	97.65 ± 0.768	97.60 ± 0.760
Pulse rate	73.70 ± 5.415	73.52 ± 3.674	74.00 ± 4.167	74.02 ± 3.437	74.12 ± 3.833	73.91 ± 3.278	73.70 ± 3.385	73.26 ± 7.088
Rhythm	1.01 ± 0.108	1.00 ± 0.000	1.01 ± 0.108	1.00 ± 0.000	1.00 ± 0.000	1.00 ± 0.000	1.01 ± 0.108	1.00 ± 0.000
Systolic	116.10 ± 7.984	115.17 ± 6.883	115.24 ± 7.109	115.13 ± 7.077	114.44 ± 5.954	115.02 ± 6.872	115.07 ± 7.034	115.35 ± 6.938
Diastolic	81.92 ± 5.336	80.56 ± 4.258	80.79 ± 4.328	80.69 ± 4.431	79.29 ± 8.980	80.86 ± 4.355	81.26 ± 4.643	80.81 ± 3.400
Respiratory rate	16.80 ± 1.370	16.76 ± 1.354	16.63 ± 1.085	16.74 ± 1.391	16.72 ± 1.262	16.63 ± 1.208	16.58 ± 1.090	17.60 ± 8.908

Sleep quality improved significantly, with 81.4% of participants reporting optimal sleep at baseline, increasing to 100.0% by day 56, and maintaining high levels (97.7%–98.8%) through the remainder of the study. Appetite also improved, increasing from 81.4% at baseline to 100.0% by day 84, with a slight decline to 97.7% on day 98.

Bowel habits showed marked improvement, with 89.55% reporting regularity at baseline, increasing to 100.0% by day 28 and slightly decreasing to 97.7% by days 84 and 98. Stool consistency improved from 84.9% at baseline to 100.0% by day 70, with a minor drop to 95.3% on day 98.

Urine output increased from 93.0% at baseline to 100.0% by day 42 and remained at this level, except for slight decreases to 97.7% on days 56 and 98. The oral temperature remained stable throughout the study, with minor fluctuations around 97.6°F.

The pulse rate was consistent, ranging from 73.26 to 74.12 beats per minute (bpm), with no significant variation. Pulse rhythm remained stable at 1.00 during most of the study, with minimal deviations (1.01) at specific intervals. Systolic blood pressure remained steady, averaging between 114 and 116 mmHg, while diastolic blood pressure showed a slight decrease, from 81.92 mmHg at baseline to 80-81 mmHg during the study. The respiratory rate remained stable, with an average of 16.6 breaths per minute.

Overall, these findings indicate notable improvements in key physical health parameters, particularly sleep quality, appetite, bowel habits, stool consistency, and urine output, alongside stable vital signs, over the course of the study.

Systemic Examination

Table 4 summarizes the systemic examination findings at baseline and on the 84th day of the study. At baseline, all participants (100.0%) exhibited normal findings for the head, eyes, ears, nose, throat, neck, lungs, and neurological systems. By the 84th day, these findings remained largely stable, with only a slight reduction in normal respiratory system findings, where chest and lung assessments decreased from 100.0% to 98.8%.

Table 4.

Systemic Examination

Systemic examination	Baseline	84th day
Head	86 (100.0%)	86 (100.0%)
Eye	86 (100.0%)	86 (100.0%)
Ear	86 (100.0%)	86 (100.0%)
Nose	86 (100.0%)	86 (100.0%)
Throat	86 (100.0%)	86 (100.0%)
Neck	86 (100.0%)	86 (100.0%)
Respiratory system chest	86 (100.0%)	85 (98.8%)
Respiratory system lungs	86 (100.0%)	85 (98.8%)
Cardiovascular system	85 (98.8%)	86 (100.0%)
Gastro-intestinal system/ Abdomen	84 (97.7%)	86 (100.0%)
Ano-rectal	85 (98.8%)	86 (100.0%)
Genitourinary system	85 (98.8%)	85 (98.8%)
Musculoskeletal system	82 (95.3%)	85 (98.8%)
Lymph nodes	85 (98.8%)	86 (100.0%)
Skin	84 (97.7%)	85 (98.8%)
Neurological	86 (100.0%)	86 (100.0%)

In contrast, improvements were observed in other systems. The cardiovascular system and gastrointestinal system/abdomen findings increased from 98.8% and 97.7% at baseline to 100.0%, respectively, by day 84. Similarly, normal findings in the musculoskeletal system improved from 95.3% at baseline to 98.8%.

The genitourinary system findings remained consistent at 98.8% throughout the study period. The skin examination findings showed an improvement, with normal findings increasing from 97.7% at baseline to 98.8% by day 84.

These results indicate overall stability and minor improvements in systemic health parameters across various organ systems over the study period.

Laboratory Investigations

The effect of treatment on laboratory parameters, measured at baseline and on the 84th day, along with their respective P-values calculated using a paired t-test, is presented in Table 5.

Table 5.

Effect of Treatment on Lab Investigations

Lab investigations		Baseline	84th day	P-Value a
Haemoglobin (g/dl)		13.52 ± 2.101	13.25 ± 2.158	0.001
TLC / cu.mm		4043.04 ± 3763.292	4269.55 ± 3920.561	0.105
DLC	N%	57.52 ± 8.966	58.01 ± 9.687	0.621
	E%	3.40 ± 2.220	4.31 ± 11.209	0.463
	B%	0.68 ± 0.430	0.63 ± 0.362	0.324
	L%	32.21 ± 8.385	32.18 ± 6.806	0.967
	M%	5.27 ± 2.176	5.25 ± 1.974	0.867
ESR (in mm) (at the end of 1st hour)		18.40 ± 15.863	20.22 ± 18.906	0.220
HbA1c (%)		5.65 ± 0.458	5.64 ± 0.543	0.839
Blood urea (mg/dl)		17.39 ± 4.715	18.68 ± 5.219	0.015
Serum creatinine (mg/dl)		0.71 ± 0.149	0.73 ± 0.137	0.047
Serum uric acid (mg/dL)		4.92 ± 1.448	4.78 ± 3.48	0.496
SGOT (AST) (IU/L)		20.91 ± 8.817	20.81 ± 11.356	0.924
SGPT (ALT) (IU/L)		25.55 ± 17.458	25.94 ± 22.574	0.818
Total protein (gm/dl)		7.44 ± 0.418	7.42 ± 0.462	0.626
Serum albumin (gm/dl)		4.49 ± 0.352	4.39 ± 0.409	0.031
Serum globulin (gm/dl)		2.97 ± 0.346	3.05 ± 0.668	0.297
A/G ratio		1.53 ± 0.225	1.49 ± 0.221	0.060
Serum bilirubin (mg/dl)		0.71 ± 1.605	0.48 ± 0.270	0.195
Serum alkaline phosphatase (IU)		81.95 ± 25.560	76.70 ± 26.408	0.023
Serum HDLc		41.89 ± 8.465	42.39 ± 14.549	0.719
Serum LDLc		116.22 ± 26.579	109.89 ± 30.508	0.033
Serum VLDLc		30.26 ± 42.461	29.04 ± 19.141	0.794
Serum cholesterol		176.56 ± 36.590	164.71 ± 44.653	0.002
Serum triglycerides		128.53 ± 59.513	131.57 ± 57.350	0.574
Cholesterol/ HDL ratio		4.78 ± 3.48	4.45 ± 1.26	0.280

^aCalculated through paired t-test.

Haemoglobin levels decreased significantly from 13.52 ± 2.101 g/dL to 13.25 ± 2.158 g/dL (P = 0.001). The total leukocyte count (TLC) showed a slight increase from 4043.04 ± 3763.292/cu.mm to 4269.55 ± 3920.561/cu.mm, but this change was not statistically significant (P = 0.105). The parameters of the differential leukocyte count (DLC)—including neutrophils, eosinophils, basophils, lymphocytes, and monocytes—did not demonstrate significant changes. The erythrocyte sedimentation rate (ESR) increased from 18.40 ± 15.863 mm to 20.22 ± 18.906 mm, though the change was not statistically significant (P = 0.220).

The HbA1c levels remained stable, with values of 5.65 ± 0.458% at baseline and 5.64 ± 0.543% on day 84 (P = 0.839). Blood urea and serum creatinine levels showed statistically significant increases, with P-values of 0.015 and 0.047, respectively. Other parameters, including serum uric acid, SGOT (AST), SGPT (ALT), total protein, serum globulin, and serum bilirubin, did not show significant changes. However, serum albumin levels decreased significantly from 4.49 ± 0.352 gm/dL to 4.39 ± 0.409 gm/dL (P = 0.031).

Among the lipid profile parameters, significant reductions were observed in serum cholesterol levels, which decreased from 176.56 ± 36.590 mg/dL to 164.71 ± 44.653 mg/dL (P = 0.002), and in serum LDL cholesterol levels (P = 0.033). Serum alkaline phosphatase levels also showed a significant reduction (P = 0.023). However, no significant changes were observed in serum HDLc, VLDLc, triglycerides, or the cholesterol/HDL ratio.

These results indicate significant effects of the treatment on certain haematological, renal, and lipid parameters, while other markers remained unchanged.

Occurrence of Adverse Drug Reactions

The study evaluates the occurrence of adverse drug reactions (ADRs), the need for concomitant or rescue medication, and adverse events over a period of 84 days, which are critical parameters for assessing the safety and tolerability of the intervention. At baseline, none of the participants required concomitant medication (0.0%); however, a small fraction (1.2%) reported this need on the 28th and 42nd days. This requirement was transient, as no participants required concomitant medication on the 56th and 70th days, with 1 participant (1.2%) reporting such a need again on the 84th day. These minimal and infrequent occurrences suggest that the requirements for concomitant medication were likely unrelated to the intervention. The need for rescue medication was observed only on the 56th day in 2.3% of participants, while no such requirement was reported at any other time point, including baseline. This isolated event indicates no consistent or significant discomfort necessitated additional treatment. Notably, no adverse drug reactions (ADRs) or adverse events (AEs) were reported throughout the entire study duration, from baseline to the 84th day (0.0%), emphasizing the intervention’s excellent safety and tolerability. Overall, the data highlight the intervention’s favourable safety profile, with no reported ADRs and minimal, sporadic requirements for additional medications. This further reinforces its suitability for long-term use without significant risks.

Discussion

From an Ayurvedic perspective, obesity (Sthaulya) arises due to an imbalance of the 3 primary regulatory systems (doshas): Kapha, Pitta, and Vata. Among these, specific subtypes such as Kledaka Kapha (responsible for moisture and heaviness), Pachaka Pitta (regulating digestion and metabolism), and Vyana and Samana Vayu (governing circulation and digestion) play key roles. Their imbalance leads to the production of ama (toxic, undigested metabolic by-products), which blocks the fat metabolism pathways (Medovaha Srotas). This disruption weakens the metabolic fire (Medodhatvagni), essential for processing fat, resulting in the accumulation of fatty tissue (Meda Dhatu). The excess fat is redistributed by the imbalanced Vyana Vayu to areas such as the abdomen, hips, breasts, and neck, causing visible symptoms like corpulence, heaviness, and difficulty in movement. Additionally, the obstruction caused by Ama and fat deposits affects the nourishment of other tissues, further aggravating the condition. This framework highlights obesity as a multi-faceted disorder involving poor digestion, fat accumulation, and metabolic channel blockages, emphasizing the intricate interplay of metabolic and structural imbalances.^20,21

Vidanga (Embelia ribes), which is a main ingredient in VDC, is a pivotal Ayurvedic herb frequently prescribed for obesity management. Preclinical studies have validated its lipid-lowering and anti-obesity effects. Notably, the ethanolic extract of Vidanga demonstrated a significant reduction in serum lipase activity, total cholesterol, and triglycerides, alongside an increase in HDL cholesterol levels in diabetic and high-fat diet-induced obesity models.^22,23 These findings suggest its potential to prevent lipid abnormalities, insulin resistance, and adiposity. The observed effects are potentially mediated by embelin, a bioactive compound that inhibits adipogenesis and lipogenesis via the canonical Wnt signaling pathway. ²⁴ Additionally, embelin’s antioxidant properties may contribute to its efficacy in addressing obesity-related oxidative stress. ²⁵ These mechanisms align well with Ayurvedic principles, where Vidanga’s Katu (pungent) and Tikta (bitter) properties, combined with its Laghu (light) and Ruksha (dry) qualities, support its Kaphashamaka (Kapha-reducing) and Medohara (fat-reducing) actions. ²⁶

VSG comprises a synergistic combination of Ayurvedic herbs, including Shunthi (ginger), Pippali (long piper), Haritaki (chebulic myrobalan), Vibhitaka (belliric myrobalan), Amalaki (Indian gooseberry), Kanchanaara (Bauhinia), Guggulu (Indian bdellium), and Madhu (honey), each contributing distinct therapeutic properties. The predominant Katu (pungent) and Tikta (bitter) taste, along with Laghu (light), Ruksha (rough), and Ushna Veerya (hot potency), enhance digestive fire (Jatharagni) and metabolic fire (Dhatwagni). ²⁷ The Lekhana Guna (scraping property) of Tikta Rasa (bitter taste) facilitates the removal of excessive Kapha and Meda from the Srotas. Furthermore, Katu Vipaka (pungent post-digestive effect) stimulates metabolic processes and reduces Kapha and fat deposition. ²⁸ Research on Vyoshadi Guggulu has demonstrated its efficacy in preventing weight gain, reducing cholesterol levels, and alleviating metabolic disorders. ²⁹ The collective action of its ingredients targets Kapha and Meda, addressing the primary dosha imbalances in obesity. ³⁰

The assessment of digestive strength (Ahara Shakti) was conducted based on classical Ayurvedic principles, categorizing individuals into 3 levels: Pravara (high), Madhyama (moderate), and Avara (low). Moderate digestive strength (Madhyama Ahara Shakti) refers to individuals who can digest a regular quantity of food without discomfort but may experience occasional variations in digestion due to dietary choices, meal timing, or minor lifestyle factors. They typically maintain stable energy levels and do not experience frequent digestive issues like bloating, indigestion, or heaviness after meals. This classification was determined through clinical observation and structured questioning by Ayurvedic physicians, evaluating factors such as appetite consistency, post-meal satiety, and tolerance to various food types.

At baseline, 36 participants (41.9%) reported dyspnea on exertion (DOE), suggesting that despite having a moderate level of physical activity capacity (Vyayama Shakti), a significant proportion of individuals still experienced difficulty in breathing during exertion. This could be attributed to excess body weight, central obesity, or poor cardiorespiratory adaptation, which is often seen in individuals with mild to moderate obesity. The Ayurvedic assessment of Vyayama Shakti (physical endurance) classified most participants as having a moderate level of physical strength, which refers to their general ability to perform routine activities rather than their cardiorespiratory fitness during intense exertion. The significant reduction in DOE over the study period indicates that the intervention helped improve fat metabolism and respiratory function, thereby reducing symptoms associated with excess weight. The observation that pulse rate remained within the normal range throughout the study further supports the conclusion that DOE was more likely related to obesity-induced exertional strain rather than an underlying cardiovascular abnormality.

The findings of the study align with Ayurvedic principles and preclinical evidence. Significant reductions were observed in BMI (P = 0.016) and waist circumference (P = 0.043), indicating a tangible impact on adipose tissue and abdominal fat distribution. ³¹ However, weight reduction, while apparent, did not achieve statistical significance (P = 0.113), suggesting that the primary effect may involve fat redistribution or metabolic improvements rather than outright weight loss. ³² The OWL-QoL score, although improved, did not reach statistical significance (P = 0.186), possibly reflecting the subjective nature of quality-of-life measures and the need for larger sample sizes to detect such changes. ³³

The significant reductions in total cholesterol (P = 0.002) and LDL cholesterol (P = 0.033) observed in this study, alongside stable HDL levels, highlight the lipid-lowering potential of the interventions. ³⁴ It suggests a potential cardiovascular benefit of Ayurvedic interventions, particularly in managing dyslipidemia associated with obesity. These improvements align with previous research on the lipid-modulating effects of Vidanga (Embelia ribes) and Vyoshadi Guggulu, both of which have been documented to enhance lipid metabolism and reduce atherogenic risk factors. However, triglyceride levels and glycemic markers (HbA1c) did not exhibit statistically significant changes, indicating that while the intervention may have effectively targeted cholesterol metabolism, its impact on glucose regulation and triglyceride metabolism was limited.^35,36 This could be attributed to multiple factors, including the mechanistic differences in Ayurvedic formulations such as VSG and VDC, which primarily act on Meda Dhatu (fat tissue) and Kapha dosha, making them more closely linked to lipid metabolism rather than direct glucose homeostasis. ³⁷ Additionally, the 12-week study duration may not have been sufficient to observe significant changes in HbA1c, which reflects long-term glycemic control over approximately 3 months. Variability in participant adherence to dietary and physical activity recommendations could also have influenced metabolic outcomes. Furthermore, while VSG and VDC are known for their lipid-lowering and metabolic-enhancing properties, additional Ayurvedic formulations with documented hypoglycemic effects, such as Guduchi, Shilajit, or Vijaysar, might be required for more pronounced effects on glucose metabolism. ³⁸ Future studies with longer follow-up periods, dietary standardization, and a more comprehensive metabolic panel may help elucidate the full extent of these formulations’ impact on both lipid and glucose metabolism.

The statistically significant reductions in BMI (P = 0.016) and waist circumference (P = 0.043) reflect the interventions’ ability to address central adiposity, a critical factor in metabolic syndrome and obesity-related health risks. ³⁹ However, the lack of significant weight reduction (P = 0.113) highlights the need for further exploration into body composition changes, such as reductions in fat mass vs lean mass. Advanced techniques such as bioimpedance analysis or DEXA scans could provide more granular insights into these outcomes. ⁴⁰ Moreover, the observed reductions in waist circumference are clinically relevant, as they are associated with decreased visceral fat, a major contributor to obesity-related comorbidities. ⁴¹

The improvements noted in systemic and physical examinations underscore the holistic benefits of the interventions. Parameters such as sleep quality, appetite, and bowel habits showed marked improvement, reaching optimal levels for most participants by the 98th day. These findings align with the Ayurvedic concept of improving Agni (digestive fire) and reducing Srotorodha (channel obstructions), which contribute to overall systemic health.^42,43 The stability of vital signs, including blood pressure, pulse rate, and respiratory rate, further supports the safety and tolerability of the trial drugs. ⁴⁴

The absence of adverse drug reactions or events throughout the study reinforces the safety of VDC and VSG at the prescribed doses. Liver and renal function tests remained within normal limits, highlighting the non-toxic nature of the interventions. ⁴⁵ However, the significant decreases in hemoglobin (P = 0.001) and serum albumin (P = 0.031), although minor, warrant attention in longer-term studies. These changes could be influenced by dietary, metabolic, or treatment-related factors and should be monitored in future trials.^46,47

While the study demonstrated significant improvements in key anthropometric and biochemical parameters, certain limitations warrant discussion. The lack of significant weight loss and quality-of-life improvements may be attributed to sample size constraints, inter-individual variability, or the relatively short duration of intervention. ⁴⁸ Additionally, the reliance on BMI as a primary outcome measure may underestimate changes in body composition, which could be better assessed through advanced imaging techniques or bioimpedance analysis. ⁴⁹ Future studies should incorporate larger sample sizes, extended durations, and a broader array of outcome measures to validate and extend these findings.

The lack of significant changes in certain lipid profile parameters and HbA1c levels suggests that the interventions may be more effective in addressing lipid metabolism rather than glucose metabolism. ⁵⁰ This finding aligns with the pharmacological properties of the trial drugs, which predominantly target Meda dhatu (adipose tissue) and Kapha dosha. ⁵¹

The study highlights the potential of Ayurvedic interventions, particularly VDC and VSG, in managing obesity by targeting dosha imbalances, metabolic dysregulation, and lipid abnormalities. ⁵² The significant reductions in BMI, waist circumference, and lipid parameters, coupled with an excellent safety profile, underscore their utility as complementary therapeutic options. ⁵³ However, further research is required to optimize dosing, treatment duration, and patient selection to maximize clinical outcomes.

This integrative approach, combining Ayurvedic principles with modern scientific validation, represents a promising avenue for addressing the multifaceted challenge of obesity like chronic health related issues.^54,55 Future studies should focus on elucidating the mechanisms underlying the observed effects, incorporating larger sample sizes, and extending the duration of intervention to assess long-term benefits and safety. By bridging traditional wisdom with modern research methodologies, Ayurvedic interventions like VDC and VSG can play a pivotal role in addressing the global obesity epidemic.

While weight reduction and lipid profile improvements can often be achieved through diet and exercise,^56,57 the novelty of this study lies in its scientific validation of Ayurvedic interventions as a complementary approach to obesity management. Unlike conventional diet-exercise regimens, which primarily focus on caloric restriction and physical activity, the Ayurvedic formulations VSG and VDC work through holistic metabolic modulation, targeting Meda Dhatu (fat tissue), Agni (digestive fire), and Srotas (metabolic channels). The significant improvements in BMI, waist circumference, and cholesterol levels demonstrate the potential of these interventions in enhancing lipid metabolism and systemic balance, even without strict caloric restriction or high-intensity exercise. Moreover, the study establishes safety and tolerability of these formulations, making them a viable option for individuals who may struggle with conventional weight-loss methods due to lifestyle limitations, metabolic resistance, or medical conditions. Future research integrating diet-exercise with Ayurvedic interventions could provide deeper insights into their combined efficacy for sustainable obesity management.

Conclusion

The findings of the present study indicate that the combination of VDC and VSG produced statistically significant improvements in key obesity-related parameters, including reductions in BMI, waist circumference, and serum cholesterol levels—critical indicators of metabolic health and central adiposity. These outcomes underscore the potential of these interventions in managing obesity and associated metabolic disorders, particularly given the strong correlation between reduced BMI and waist circumference and a decreased risk of obesity-related complications such as cardiovascular diseases and metabolic syndrome. Participants reported substantial alleviation of symptoms such as polyphagia, polydipsia, excessive sweating, excessive sleep, body fatigue, and dyspnea on exertion, suggesting a comprehensive enhancement in both metabolic and systemic functions and an overall improvement in quality of life. The absence of adverse drug reactions or significant deviations in liver and renal function tests reinforces the safety of VDC and VSG, making them suitable for prolonged use. From an Ayurvedic perspective, the interventions effectively address dosha imbalances and srotas obstructions associated with obesity, promoting improved Agni (digestive fire) and metabolic regulation, with lipid-lowering effects aligning with traditional claims of Medohara (fat-reducing) and Kaphashamaka (Kapha-reducing) properties. These findings highlight the relevance of integrating traditional Ayurvedic therapies with evidence-based approaches for obesity management. However, further research with larger sample sizes, extended follow-up periods, and advanced methodologies is recommended to validate and expand upon these findings, paving the way for broader clinical application.

Limitations and Recommendations

While demonstrating promising results, this study has several limitations that warrant attention. The relatively small sample size and open-label, single-arm design limit the generalizability and robustness of the findings. The lack of a control or placebo group restricts the ability to distinguish the intervention’s effects from placebo effects. Furthermore, the 12-week duration, with a 2-week follow-up, may not have been sufficient to observe the long-term efficacy or sustainability of the outcomes. The reliance on BMI and waist circumference as primary outcome measures, without advanced tools like DEXA scans or bioimpedance analysis, limits insights into changes in body composition. While improvements in lipid profiles were observed, other parameters like triglycerides and HbA1c remained unchanged, indicating a need for broader metabolic evaluations. Minor but significant reductions in hemoglobin and serum albumin levels also require further investigation to determine their clinical relevance. Future studies should focus on addressing these limitations by incorporating randomized controlled designs, larger and more diverse sample sizes, and extended follow-up periods. Standardization of dietary and lifestyle factors, along with advanced body composition analysis, would enhance the precision of results. The differing climates of Bengaluru (moderate and humid) and Jaipur (hot and dry) may have influenced participants’ digestion (Agni) and food intake. According to Ayurveda, climate affects Dosha balance, with Jaipur’s heat potentially aggravating Pitta dosha, impacting metabolism, while Bengaluru’s milder climate may support stable digestion. These variations could have contributed to differences in dietary habits and metabolic responses. Future studies should consider regional climatic influences to better understand their effect on digestion and treatment outcomes. Additionally, integrating comprehensive biochemical and patient-reported outcome assessments and exploring the pharmacological mechanisms of the formulations would provide deeper insights. These steps, combined with long-term safety monitoring and comparative trials against conventional treatments, can strengthen the evidence base for integrating Ayurvedic therapies like Vidanga Churna (VDC) and Vyoshadi Guggulu (VSG) into modern obesity management practices.

ORCID iD

Bidhan Mahajon https://orcid.org/0000-0002-9685-5788

Ethical Considerations

This study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and adhered to the Ethical Guidelines for Biomedical Research on Human Participants issued by the Indian Council of Medical Research (ICMR, 2017). Ethical approval for the study was obtained from the Institutional Ethics Committees (IEC) of both participating centers: the Central Ayurveda Research Institute (CARI), Bengaluru (approval number: F.6-5/RARIMD/BNG/IEC Meet/2020-21, dated 26.09.2020), and the M.S. Regional Ayurveda Research Institute (MSRARI), Jaipur (approval number: F.5/Lab/Pre-iron/Ethics/2007-08/CRAI-JPR, dated 04.07.2020). The study was registered with the Clinical Trials Registry of India (CTRI/2022/05/042681) before participant recruitment. Written informed consent was obtained from all participants after they were provided with comprehensive information about the study’s objectives, procedures, potential benefits, and risks. Participants were assured of their right to withdraw from the study at any time without any implications. The confidentiality of all participant data was strictly maintained throughout the study, and no identifying information was disclosed. The study adhered to Good Clinical Practice (GCP) guidelines to ensure the integrity and ethical rigour of the research process.

Consent to Participate

Written informed consent to participate in the study was obtained from all participants prior to their inclusion. Participants were provided with detailed information about the study’s objectives, procedures, potential benefits, and risks in a language they could understand. They were also informed about their right to withdraw from the study at any time without any consequences. The consent process adhered to the guidelines of the Institutional Ethics Committees (IEC) of the Central Ayurveda Research Institute (CARI), Bengaluru, and the M.S. Regional Ayurveda Research Institute (MSRARI), Jaipur. No participant was enrolled in the study without providing written consent.

Data Availability Statement

The data supporting the findings of this study are available from the authors upon reasonable request. The study adhered to the principles of transparency and reproducibility, and all relevant data were collected, stored, and managed following Good Clinical Practice (GCP) guidelines. Due to ethical and privacy considerations, individual participant data cannot be shared publicly. Aggregated and anonymized datasets, however, may be made available for legitimate academic and research purposes upon approval by the cometent authority and the institutional ethics committee.*