A protocol for an open-label randomized parallel group clinical study on non-alcoholic fatty liver disease (NAFLD)

Abstract

The primary objective of this study is to evaluate the efficacy of the combined effect of Agnideepan and Vyadhipratyaneek Chikitsa on the Fatty Liver Index (FLI) score in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Secondary objectives include assessing the impact of combined chikitsa on Agni, lipid profile, body weight, waist circumference, and BMI. The study also aims to evaluate the effects of Vyadhi Pratyaneekachikitsa on changes in the FLI, lipid profile, body weight, waist circumference, BMI, and Agni, as well as the impact of Agni Deepanchikitsa on these parameters. Additionally, the quality of life of NAFLD patients will be evaluated using the SF36 questionnaire. Patients diagnosed with NAFLD will be selected from the outpatient department of CARICD, now renamed the Central Ayurveda Research Institute in New Delhi. Patient information sheets and consent forms will be provided to all willing participants. Screening will be conducted, and suitable patients will be randomized using a computer-generated chart. Trial formulations will be prescribed according to a set schedule, and patients will be called for follow-up visits accordingly. It is expected that the combined treatment of Agnideepan and Vyadhipratyaneek Chikitsa will be more effective than Vyadhipratyaneek Chikitsa alone in managing NAFLD. This study aims to explore the effectiveness of Ayurveda interventions in managing NAFLD through a disease-specific approach to precisely correct RaktavahaSrotodushti with Yakrt involvement and a general approach aimed at correcting metabolism. This dual approach highlights the role of multiple therapeutic targets in disease management tailored to patient-specific factor.