Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Picroliv 100mg twice daily: Picroliv 100mg twice daily for 24 weeks + standard therapy of NAFLD
Control Intervention1: Placebo: Placebo for 24 weeks+ standard therapy of NAFLD
Sponsors
Director, CSIR-Central Drug Research Institute
CSIR Institute of Himalayan Bioresource Technology CSIRIHBT
Indian Council of Medical Research ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: 1. Significant alcohol consumption ( > 210 g/week in males and > 70 g/week in females) 2. eGFR 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)Timepoint: Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 24 in clinical laboratory variables of lipid profileTimepoint: 0,12,24 weeks;Change from baseline to week 24 in clinical laboratory variables of Liver functionTimepoint: 0, 12, 24 weeks;Change from baseline to Week 24 in hepatic stiffness by transient elastographyTimepoint: 0 and 24 weeks;Change from baseline to week 24 in Liver indices / scores – NAFLD fibrosis score, FIB4 index, ELF score, Fatty Liver Index, APRI..Timepoint: 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 otherTimepoint: 0,2,4, 8, 12, 18, 24 weeks | — |
Countries
India
Contacts
Public ContactDr Vivek Bhosale
CSIR-Central Drug Research Institute, Lucknow
Outcome results
None listed