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

NCT07452744 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-03-12

No results posted yet for this 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.

Conditions

  • Non Alcholic Fatty Liver Disease

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.

Sponsors & Collaborators

  • Bioagile Therapeutics Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr Vivek Bhosale · CDRI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2026-07-15
Completion
2026-08-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452744 on ClinicalTrials.gov