Research Protocol
Comparative Evaluation of Efficacy of Gomutra Haritaki versus Atorvastatin in the Management of Obesity: A Randomised Single-blind Standard Control Clinical Trial Protocol
JK01-JK05
Correspondence
Shweta Parwe,
Professor and Head, Department of Panchakarma, Mahatma Gandhi Ayurveda College Hospital and Research Centre, Wardha, Maharashtra, India.
E-mail: shweta.parwe@dmiher.edu.in
Introduction: Obesity is a significant global health concern and is often associated with various complications, including cardiovascular diseases and metabolic disorders. Although drugs such as Atorvastatin are routinely employed to control lipid disturbances, they have unwanted side effects. Gomutra Haritaki, a traditional Ayurvedic remedy, offers a potential natural and holistic alternative.
Need of the study: The present research may shape integrative treatment strategies for obesity, a condition whose prevalence has more than doubled globally since 1990, affecting 16% of adults by 2022 {World Health Organisation (WHO)}. Gomutra Haritaki, as mentioned in Charaka and Sushruta Samh.ita, enhances digestion, metabolism, and fat reduction through its Ushn. a Virya, thereby balancing Kapha and Meda. In contrast, statins, though effective, can cause myalgia (1-10%), rare rhabdomyolysis (<0.1%), and occasionally affect liver function (˜1%) or increase diabetes risk. Risk factors include alcohol use, polypharmacy, and hypothyroidism.
Aim: To evaluate and compare the efficacy of Gomutra Haritaki and Atorvastatin in reducing obesity-related parameters such as weight, Body Mass Index (BMI), lipid profile, and waist-hip ratio in adult patients.
Materials and Methods: The present research will be a single-blind, randomised, standard-controlled trial with 40 participants who have newly diagnosed cases of obesity in the age group 20-40 years and a BMI>30 kg/m². Group A participants will be administered Gomutra Haritaki-3 g/day (3 tab twice daily), and Group B participants will be given Atorvastatin (10 mg daily). Both Gomutra Haritaki and Atorvastatin will be administered for a period of 60 consecutive days.
The trial will be conducted at Mahatma Gandhi Ayurved College and Hospital and Research Centre, Salod, Wardha, Maharashtra, India, between March 2025 and January 2026. Objective parameters, weight, BMI, lipid profile, and hip to waist ratio will be assessed on 0, 15th, 30th, and 60th days. Paired and unpaired t-tests will analyse data, with p<0.05 considered significant. Statistical analysis will be performed using Statistical Package for Social Sciences (SPSS) version 17.0.