Pharmacognostic and Phytochemical Standardization of Vasaguduchyadi Ghanavati and its Preclinical Safety and Clinical Efficacy in Non-Alcoholic Fatty Liver Disease

A single-blind, randomized, interventional clinical trial will be conducted at the OPD and IPD units of IPGAE&R, Kolkata, to evaluate the efficacy of Vasaguluchyadi Ghanavati in the management of Non-Alcoholic Fatty Liver Disease (NAFLD) up to Grade II. The study will enroll a minimum of 84 participants (42 per group).Group A (Test Group) Will receive Vasaguluchyadi Ghanavati for 90 days.Group B (Control Group): Will receive Vasaguluchyadi Kashayam for 90 days.Primary Objective to evaluate the preclinical safety and clinical efficacy including patient-compliance of Vasaguluchyadi Ghanavati in the management of Non-Alcoholic Fatty Liver Disease (NAFLD) up to Grade II, after its pharmacognostic and phytochemical standardization.Secondary Objectives 1. To carry out pharmacognostic identification and standardization of raw herbal ingredients used in Vasaguluchyadi Ghanavati as per classical and modern parameters. 2. To conduct physicochemical and phytochemical profiling of the prepared formulation using standard methods (e.g., HPTLC, TLC, UV-Vis). 3. To perform acute toxicity studies of the formulation in animal models, adhering to OECD guidelines for safety evaluation. 4. To assess the clinical outcomes of Vasaguluchyadi Ghanavati in NAFLD patients (Grade I–II), based on liver function tests, imaging findings (e.g., USG), and validated symptom scoring. 5. To evaluate the organoleptic and patient compliance profile of the Ghanavati form in comparison to the traditional Kashayam.