Efficacy of Ayurveda interventions and lifestyle versus lifestyle interventions alone in grade I and II non-alcoholic fatty liver disease: Protocol for a multicenter exploratory pilot randomized controlled trial

Abstract

INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is a worldwide public health issue affecting 20%–30% of adults, with dominance in men, particularly in the obese population. Current interventions focus on lifestyle modifications, highlighting the need for effective pharmacological options. This study explores the clinical efficacy of Arogyavardhini Vati and Pippalyadyasava, traditional Ayurvedic formulations, in the management of NAFLD. BACKGROUND AND RATIONALE: With Ayurvedic medicine emphasizing holistic well-being, this study is aimed to assess the efficacy of Ayurveda interventions viz., Arogyavardhini Vati and Pippalyadyasava combined with lifestyle modifications in grade I and II NAFLD. MATERIALS AND METHODS: The study includes individuals aged 18–60 years and diagnosed with NAFLD of grade I or II. The intervention arm receives Arogyavardhini Vati and Pippalyadyasava along with lifestyle modifications, while the control group adopts lifestyle modifications for 90 days. Both groups are then followed up for more than 30 days with lifestyle modifications ongoing. Primary outcomes include the change in the fibroscan score and controlled attenuation parameter value or magnetic resonance imaging proton density fat fraction. Secondary outcomes are changes in liver function markers, lipid profile, HbA1C, Body Mass Index, and Fatty Liver Index. CONCLUSION: This study may inform about the efficacy of the Ayurvedic interventions adjuvant to lifestyle modification in the management of NAFLD. TRIAL REGISTRATION: CTRI/2022/02/040321 dated February 15, 2022.