Efficacy of Mushkakadi Gana Udvartana versus Triphala Gana Udvartana in the Management of Obesity (Sthoulya): A Randomised Control Trial Protocol

Introduction: Obesity, as defined by the World Health Organisation (WHO), is a condition characterised by excessive fat accumulation, marked by a Body Mass Index (BMI) of 30 kg/m² or higher, and associated with substantial health complications. Its global prevalence is heterogeneous, affecting approximately 67% of the population in America and 31% in Southeast Asia and Africa. By 2027, it is estimated that 16% of adults will be classified as obese. This condition adversely impacts both physical and mental health and serves as a precursor to numerous co-morbidities, including diabetes, hypertension, atherosclerosis, gallstones, osteoarthritis, and infertility. In Ayurveda, obesity is correlated with Sthoulya, a metabolic disorder resulting from impaired anabolic processes. Need of the study: Obesity, recognised as a global epidemic by WHO, is primarily driven by sedentary lifestyles. It is strongly associated with an increased risk of hypertension, type 2 diabetes, coronary heart disease, hyperlipidaemia, arthritis, and several cancers, including those of the colon, gallbladder, biliary tract, breast, endometrium, and cervix. As obesity rates continue to rise, exploring natural remedies such as dry powder massage (Udvartana) is essential for effective weight management and symptom relief while minimising adverse side-effects. Pharmacological selection plays a crucial role in Ayurvedic management. The Mushkakadi Gana group of drugs, known for its Kapha-pacifying (Kaphagna) and fat-reducing (Medogna) properties, shows therapeutic potential. However, clinical trials evaluating its efficacy are limited. Aim: To evaluate the efficacy of Mushkakadi Gana Udvartana and Triphala Gana Udvartana in the management of obesity (Sthoulya). Materials and Methods: This study is designed as a randomised controlled trial and will be conducted at Mahatma Gandhi Ayurved College, Hospital, and Research Centre, Salod, Hirapur (H), Maharashtra, India over a period of 18 months (January 2025 to January 2026). A total of 60 patients will be enrolled and randomly divided into two groups. Group A (n=30): Will receive Udvartana with Triphala Gana Churna (control group). Group B (n=30): Will receive Udvartana with Mushkakadi Gana Churna (experimental group). The intervention will be administered for a duration of 15 days. Therapeutic outcomes will include reduction in body weight, BMI, skin fold thickness, anthropometric measurements, and serum lipid profile. Statistical analysis will be performed using Statistical Package for the social sciences (SPSS) version 17.0 software. An independent sample t-test will be used to compare baseline characteristics between groups, and a paired t-test will be applied for within-group comparisons. A p-value <0.05 will be considered statistically significant.