Clinical Trial

Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease

Enrolling by Invitation
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Record status
This record was last updated March 12, 2026 (before its estimated July 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study designed to evaluate the efficacy and safety of a standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) in adults with Non-Alcoholic Fatty Liver Disease (NAFLD). A total of 170 adults aged 18-60 years with uncomplicated NAFLD (fibrosis stage up to F2) will be randomized in a 2:1 ratio to receive either Picroliv 100 mg capsules twice daily or matching placebo, in addition to standard of care, for a treatment duration of 24 weeks. Standard of care includes dietary and lifestyle modifications, exercise recommendations, and management of comorbid conditions as per routine clinical practice. The study aims to assess the efficacy of Picroliv in improving hepatic and metabolic parameters and to evaluate its safety profile compared with placebo. Participants will be followed for a total study duration of 48 weeks. The trial will be conducted across six clinical sites in India.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-27.
Trial Details
NCT Number NCT07452744
Lead Sponsor Bioagile Therapeutics Pvt. Ltd.
Conditions Non Alcholic Fatty Liver Disease
Enrollment 170 participants
Start Date 2024-08-13
Primary Completion 2026-07-15 (estimated)
Study Completion 2026-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-12