Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT07452744
NA

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

Sponsor: Bioagile Therapeutics Pvt. Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

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