Efficacy of Haritaki Vati (Terminalia Chebula Retz.) in Sthaulya (Overweight): A Randomised Controlled Trial Research Protocol

Introduction: Overweight or Sthaulya is one of the Ashtaunindita Purusha or eight undesirable body constitutions according to Ayurveda. It is directly associated with noncommunicable diseases like diabetes, cardiovascular disease, and hypertension, therefore being one of the most important health factors in modern medicine. Need of the study: Overweight is among the major causes of non-communicable diseases and decreased quality of life worldwide. Current treatments have very high costs and adverse effects. Haritaki is an Ayurvedic herbal medicine that is easily affordable, widely available, and safe for chronic use. However, there is a notable lack of studies assessing its effectiveness through rigorous methodologies, such as placebo-controlled and double-blind clinical trials. This study is specifically designed to fill this gap in research. Aim: To evaluate the efficacy of Haritaki Vati (Terminalia Chebula Retz.) vs routine care in the management of Sthaulya (overweight). Materials and Methods: This double-blind, randomised, placebo-controlled clinical trial will be conducted from December 2024 to December 2026 at Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod (H), Wardha. 60 participants, aged between 19 and 30 years and having a Body Mass Index (BMI) ranging from 25 to 29.9 kg/m2 , will be enrolled and randomly assigned to two groups. Group-A will receive Haritaki Vati at a dose of two grams per day, administered in two divided doses, while Group-B will receive starch-based placebo tablets. The intervention period for both groups will be 90 days, with follow-up evaluations scheduled on days 30, 60, and 90. Anthropometric parameters such as BMI, waist-tohip ratio, and mid-upper arm circumference will be recorded at baseline and during each follow-up. Statistical analysis will be carried out using paired and unpaired t-tests, and results will be considered statistically significant at a p-value of less than 0.05.