Efficacy and safety of Ayurvedic formulations Lekhaniya gana kashaya and Arogyavardhini gutika in managing obesity: A multicenter single-arm study

Background: Obesity is a chronic condition characterized by excessive fat accumulation that contributes to various Noncommunicable Diseases (NCDs). Recent studies report a 40.3% prevalence of obesity in India, with higher rates among women (41.88%) compared to men (38.67%), varying by age, location, and socioeconomic status. Considering the growing need for safe and effective long-term intervention, this study was designed, thereby contributing clinical evidence to obesity. Aim: The aim of this study was to evaluate the clinical efficacy and safety of Lekhaniya Gana Kashaya (LGK) and Arogyavardhini Gutika (AG) in improving anthropometric and metabolic parameters associated with Medoroga (~obesity) management. Materials and Methods: A prospective, single-arm, open-label interventional study was conducted at two peripheral units of Central Council for Research in Ayurvedic Sciences. A total of 100 participants diagnosed with Medoroga were enrolled according to the predefined inclusion criteria. The intervention involved the administration of LGK (50 ml orally, twice daily before meals) and AG (500 mg orally twice daily with lukewarm water after meals) for 12 weeks. This was followed by a 4-week follow-up period without medication. Outcome measures included changes in body weight, Body Mass Index (BMI), waist circumference, and scores on the Obesity and Weight Loss Quality of Life (OWLQOL) questionnaire. Fat analysis using Dual-Energy X-ray Absorptiometry (DEXA) scan was also performed. Results: The combination of LGK and AG demonstrated statistically significant reductions in BMI, waist circumference, and OWLQOL scores ( P < 0.05) compared to baseline. There were no adverse effects reported. Conclusion: The formulations exhibited promising efficacy and safety as interventions for obesity, producing significant reductions in body weight, BMI, and waist circumference, alongside improvements in overall metabolic and functional health outcomes.