Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Rosuvastatin 10mg once daily plus Saroglitazar 4 mg once daily: The intervention to be given for 52 weeks
Control Intervention1: Saroglitazar: Saroglitazar 4mg once daily for 52 weeks
Sponsors
Sanjay Gandhi post graduate institute of medical sciences
Eligibility
Inclusion criteria
Inclusion criteria: Adults with MASLD with Liver stiffness 8 to 20 Spa
Exclusion criteria
Exclusion criteria: Hepatitis B or C, Significant alcohol intake, Patients on vitamin E or saroglitazar, Cirrhosis, malignancy,Pregnancy,lactation, uncontrolled diabetes, patients on statin for cardiovascular disease,Inability to perform fibroscan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare mean reduction in liver stiffness values after 24 weeks of interventionTimepoint: To compare mean reduction in liver stiffness values after 24 weeks of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare mean reduction in liver stiffness at 52 weeks, Proportion of patients achieving decrease in at least one grade of fibrosis, Mean reduction in steatosis measured by FibroScan, Mean improvement in AST, ALT, LDL, Triglyceride, HDL, VLDL, fasting blood sugar and HOMA IR at 24 weeks, Changes in cytokeratin-18 and TNF alpha at 24 and 52 weeks of interventionTimepoint: 24 weeks and 52 weeks | — |
Countries
India
Contacts
Public ContactAjay kumar Mishra
SGPGI Lucknow
Outcome results
None listed