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

NCT07452744 | Enrolling By Invitation

• 2 other identifiers: BIAG-CSP-063CDRI-ICMR-6/2021
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in hepatic fat fraction

  Measured as the change from baseline in hepatic fat fraction (%) assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) at Week 24.

  Baseline to Week 24

Secondary Outcomes (12)

• Change in liver stiffness

  Baseline to Week 24

• Change in Serum Alanine Aminotransferase (ALT)

  Baseline to Week 24

• Change in Fasting Plasma Glucose

  Baseline to Week 24

• Change in fibrosis score

  Baseline to Week 24

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Baseline to Week 48

Study Arms (2)

Experimental arm

EXPERIMENTAL

Picroliv + Standard of Care

Drug: Picroliv

Placebo Comparator arm

PLACEBO COMPARATOR

Placebo + Standard of Care

Other: Placebo

Interventions

Picroliv DRUG

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.

Experimental arm

Placebo OTHER

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.

Placebo Comparator arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Bioagile Therapeutics Pvt. Ltd.: lead

Study Sites (6)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Nizam's Institute of Medical Sciences

Panjagutta, Hyderabad, 500082, India

Location

King George 's Medical University

Chowk, Lucknow, 226003, India

Location

King Edward Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

All India Institute of Medical Sciences

Delhi, NEW DELHI, 110029, India

Location

Institute of Liver and Biliary Sciences

Vasant Kunj, NEW DELHI, 110070, India

Location

MeSH Terms

Interventions

kutkin

Study Officials

• Dr Vivek Bhosale

  CDRI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: March 5, 2026
• Study Start: August 13, 2024
• Primary Completion: July 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)