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Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease | Clinical Trials | Clareo Health

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

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)

NCT07452744•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.

Detailed Description

Non-Alcoholic Fatty Liver Disease (NAFLD) is a highly prevalent metabolic liver disorder with limited pharmacological treatment options. Lifestyle modification remains the mainstay of management, highlighting the need for safe and effective therapeutic agents. Picroliv®, a standardized ethanolic extract of the roots and rhizomes of Picrorhiza kurroa, has demonstrated hepatoprotective, antioxidant, and anti-inflammatory properties in preclinical studies and early clinical investigations. This Phase III, multicentre, randomized, double-blind, placebo-controlled, two-arm interventional study is designed to evaluate the efficacy and safety of Picroliv in adults diagnosed with uncomplicated NAFLD (fibrosis stage up to F2). Eligible participants aged 18-60 years 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 24 weeks. Standard of care includes dietary counseling, exercise recommendations, and management of associated comorbidities as per routine clinical practice. Participants will be followed for a total study duration of 48 weeks. The study will be conducted at six clinical centers in India.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: 18- 60 years
•2. Sex: Both males and females
•3. Patients showing presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at screening.
•4. Liver enzymes normal or above the ULN (upper limit of normal range) but less than 3 times
•5. Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 109/L, and a white blood cell count ≥ 3.0 x 109/L
•6. HbA1c \< 7% (if participant has Type 2 diabetes mellitus (T2DM) should be controlled with appropriate treatment for the same except thiazolidinediones)
•7. TSH within normal limits (WNL) at screening
•8. If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study will be allowed if on stable doses in the preceding 12 weeks and will be continued throughout the study.

Exclusion Criteria

•1. Significant alcohol consumption (\> 210 g/week in males and \> 70 g/week in females)
•2. eGFR \< 60 mL/min / 1.73m2 or patients on dialysis
•3. Hepato-biliary disorders: Cirrhosis, biliary obstruction, chronic cholecystitis, cholelithiasis, active or chronic active Hepatitis B or hepatitis C, autoimmune liver diseases
•4. Medical conditions including stroke, Alzheimer's disease, tuberculosis, Ischemic Heart Disease (IHD), Deep Vein Thrombosis (DVT), pancreatitis, inflammatory rheumatic diseases, cancer or any disorder that may potentially impact the outcome measures
•5. Patients on drugs potentially associated with NAFLD such as amiodarone, methotrexate, perhexiline, estrogens, tamoxifen, nifedipine, diltiazem, chloroquine and other hepatotoxic agents as per the discretion of the study investigator.
•6. Medications for disease conditions (e.g., HIV-1, HBV, or HCV infection, active cancer, transplantation are also excluded from the study.
•7. Subjects on anti TNF therapies, other biologicals and probiotics
•8. Subjects on Thiazolidinediones (TZDs), Saroglitazar, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum marianum, Valeriana officinalis and hepatoprotective plants / Traditional medicine formulations / natural products.
•9. Subjects on medications that may affect glucose metabolism such as corticosteroids, opiates, barbiturates and anticoagulants.
•10. Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.
+4 more criteria

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

Key Dates

Start Date

August 13, 2024

Primary Completion Date

July 15, 2026

Completion Date

August 15, 2026

Last Updated

March 12, 2026

Enrollment

170

ESTIMATED participants

Conditions

Non Alcholic Fatty Liver Disease

Interventions

Picroliv

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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