Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Drugs: Obeticholic acid 10 mg with saroglitazar 4 mg
Intervention2: Drugs: Obeticholic acid 10 mg with saroglitazar 4 mg
Intervention3: Drugs: Obeticholic acid 10 mg with saroglitazar 4
Sponsors
Department of Medical gastroenterology
Eligibility
Inclusion criteria
Inclusion criteria: Adults (age 18 to 60) being managed or treated for NAFLD. •The patient must qualify for NAFLD, according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasani et al.2017). •(a) There is hepatic steatosis by imaging or histology, •(b) There is no significant alcohol consumption, •(c) There are no competing aetiologies for hepatic steatosis •(d) There are no co-existing causes for chronic liver disease. •Patientâ??s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations. •The subjects underwent Fibroscan per the protocol described prior to enrolment and subsequently, they were contacted to participate in the follow-up study at 24 . •The lipid profile range in the inclusion criteria. TG >= 150mg/dl and LDL >= 100mg /dL and HDL <= 40 mg /dL.
Exclusion criteria
Exclusion criteria: Presence of regular or excessive use of alcohol within 2 years prior to initial screening. Presence of alternative causes of fatty liver, including: History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT) History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints 1.Change in liver fat content by non-invasively measuring CAP parameters through Fibroscan at week 8 16week 24 weeks 2.Change in hepatic fibrosis assessed by non-invasively measuring LSM parameters through Fibroscan at baseline ,week 8, 16 and 24 3.To assess the change in non-invasive scoring methods like NAFLD fibrosis score, FIB 4 Score, BARD Score and FAST Score at baseline, 16 and 24 weeks 4.Compare the overall treatment efficacy in patients with NAFLD/ NASH treated with Saroglitazar magnesium 4mg and OCA 10mg.Timepoint: 6months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints 1.To assess the change in serum alanine aminotransferase (ALT) & aspartate aminotransferase (AST) level from baseline. 2.To assess the change in Lipid profile, the serum triglycerides (TG) level, high-density lipoprotein (HDL), low density lipoprotein (LDL) from baseline. To assess the change in fasting plasma glucose (FPG)/glycosylated haemoglobin (HbA1c), from baselineTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Prof GM Gulzar
Skims Srinagar
Outcome results
None listed