A Phase III clinical trial of Picroliv in the Management of Non-Alcoholic Fatty Liver Disease(NAFLD)
- Conditions
- Fatty (change of) liver, not elsewhere classified,
- Registration Number
- CTRI/2023/06/053714
- Lead Sponsor
- Director, CSIR-Central Drug Research Institute
- Brief Summary
Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem worldwide, affecting between 25% and 30% of the general population. NAFLD refers to a spectrum ranging from noninflammatory isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by steatosis, necroinflammatory changes, and varying degrees of liver fibrosis. Picrorhiza kurroa is a well-known herb in the Ayurvedic system of medicine and has traditionally been used to treat disorders of the liver. It is antioxidant and has anti-inflammatory activities. The use of Picroliv which is standardized as per phytopharmaceutical guidelines of Govt. of India for the treatment of NAFLD will be safe and effective.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 170
- 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.Adults who are diagnosed with uncomplicated NAFLD (fibrosis score up to F2) by transient elastography.
- 6.Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 109/L, and a white blood cell count ≥ 3.0 x 109/L 7.HbA1c < 7%.
- 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.Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.
- 5.Pregnant and lactating women.
- 6.Not willing to provide written informed consent 7.Females unwilling to use any form of contraception during the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
- Secondary Outcome Measures
Name Time Method Change from baseline to Week 24 in hepatic stiffness by transient elastography 0 and 24 weeks Change from baseline to week 24 in clinical laboratory variables of Liver function 0, 12, 24 weeks Change from baseline to week 24 in clinical laboratory variables of lipid profile 0,12,24 weeks Change from baseline to week 24 in Liver indices / scores – NAFLD fibrosis score, FIB4 index, ELF score, Fatty Liver Index, APRI.. 0,12,24 weeks Change in baseline clinical signs and symptoms at every follow up: Low appetite, distaste, heaviness of the abdomen, constipation, inactivity stiffness, fatigue, pain in right upper abdomen and any other 0,2,4, 8, 12, 18, 24 weeks
Trial Locations
- Locations (6)
All India Institute of Medical Sciences (AIIMS)
🇮🇳Delhi, DELHI, India
Institute of Liver and Biliary Sciences (ILBS)
🇮🇳Delhi, DELHI, India
King Edward VII Memorial Hospital (KEMH)
🇮🇳Mumbai, MAHARASHTRA, India
King’s George Medical University (KGMU)
🇮🇳Lucknow, UTTAR PRADESH, India
Nizam’s Institute of Medical Sciences (NIMS)
🇮🇳Hyderabad, TELANGANA, India
Post-Graduate Institute of Medical Education and Research, (PGIMER)
🇮🇳Chandigarh, CHANDIGARH, India
All India Institute of Medical Sciences (AIIMS)🇮🇳Delhi, DELHI, IndiaDr ShalimarPrincipal investigator011-26588500drshalimar@gmail.com