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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Non Alcholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT07452744

Run by

Bioagile Therapeutics Pvt. Ltd.

People needed

170

Starts

2024-08-13

Expected to finish

2026-08-15

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18- 60 years
• Sex: Both males and females
• Patients showing presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at screening.
• Liver enzymes normal or above the ULN (upper limit of normal range) but less than 3 times
• Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 109/L, and a white blood cell count ≥ 3.0 x 109/L
• HbA1c < 7% (if participant has Type 2 diabetes mellitus (T2DM) should be controlled with appropriate treatment for the same except thiazolidinediones)
• TSH within normal limits (WNL) at screening
• 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.

You may not qualify if…

• Significant alcohol consumption (> 210 g/week in males and > 70 g/week in females)
• eGFR < 60 mL/min / 1.73m2 or patients on dialysis
• Hepato-biliary disorders: Cirrhosis, biliary obstruction, chronic cholecystitis, cholelithiasis, active or chronic active Hepatitis B or hepatitis C, autoimmune liver diseases
• 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
• 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.
• Medications for disease conditions (e.g., HIV-1, HBV, or HCV infection, active cancer, transplantation are also excluded from the study.
• Subjects on anti TNF therapies, other biologicals and probiotics
• Subjects on Thiazolidinediones (TZDs), Saroglitazar, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum marianum, Valeriana officinalis and hepatoprotective plants / Traditional medicine formulations / natural products.
• Subjects on medications that may affect glucose metabolism such as corticosteroids, opiates, barbiturates and anticoagulants.
• Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.
• Pregnant and lactating women.
• Patients with a history of serious drug allergies (such as anaphylactic shock)
• Not willing to provide written informed consent
• Females unwilling to use any form of contraception during the trial.

Where it is running

• 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

Full record on ClinicalTrials.gov

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