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

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.
• •11. Pregnant and lactating women.
• •12. Patients with a history of serious drug allergies (such as anaphylactic shock)
• •13. Not willing to provide written informed consent
• •14. Females unwilling to use any form of contraception during the trial.