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Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease
Sponsor: Bioagile Therapeutics Pvt. Ltd.
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.
Official title: A Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled, Interventional Study on Efficacy and Safety of Standardized Fraction of Picrorhiza Kurroa Royal Ex Benth (Picroliv®) for 24 Weeks in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD)
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2024-08-13
Completion Date
2026-08-15
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
PGIMER
Chandigarh, Chandigarh, India
Nizam's Institute of Medical Sciences
Panjagutta, Hyderabad, India
King George 's Medical University
Chowk, Lucknow, India
King Edward Memorial Hospital
Mumbai, Maharashtra, India
All India Institute of Medical Sciences
Delhi, NEW DELHI, India
Institute of Liver and Biliary Sciences
Vasant Kunj, NEW DELHI, India