Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Picroliv: Participants will receive Picroliv 100 mg capsules twice daily (after meals) for 24 weeks, in addition to standard of care, which includes dietary counseling, exercise recommendations, and management of comorbid conditions as per routine clinical practice.
Placebo: Participants will receive matching placebo capsules twice daily (after meals) for 24 weeks, in addition to standard of care, which includes dietary counseling, exercise recommendations, and management of comorbid conditions as per routine clinical practice.
Study 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.
Eligibility
Primary outcome measure(s)
- Change in hepatic fat fraction — Baseline to Week 24
Measured as the change from baseline in hepatic fat fraction (%) assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) at Week 24.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| PGIMER | Chandigarh | Chandigarh | |
| Nizam's Institute of Medical Sciences | Panjagutta | Hyderabad | |
| King George 's Medical University | Chowk | Lucknow | |
| King Edward Memorial Hospital | Mumbai | Maharashtra | |
| All India Institute of Medical Sciences | Delhi | NEW DELHI | |
| Institute of Liver and Biliary Sciences | Vasant Kunj | NEW DELHI |
More Bioagile Therapeutics Pvt. Ltd. trials in India
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07452744 on ClinicalTrials.gov ↗ ← All trials in India