Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Saroglitazar: Oral tablet,4mg once daily for 6 months
Intervention2: Vitamin E: Oral tablet, 400mg twice daily for 6 months
Intervention3: Saroglitazar plus Vitamin E combination: Oral
Sponsors
Bilal Ahmad Mir
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Confirmed Diagnosis of NAFLD established either by imaging or liver biopsy according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasaniet al.2017). 2. Adults ( >18years)
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Absence of regular or excessive use of alcohol within 2 years prior to initial screening. 2. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis. 3. Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or Imaging techniques. 4. Patients with Hypothyroidism and celiac disease. 5. Presence of alternative causes of fatty liver, including: Weight loss >10% in the 6 months before the Screening Visit Total parenteral nutrition, starvation or protein-calorie malnutrition Use of drugs associated with NAFLD. 6. History of malignancy in the past 5 years and/or active neoplasm 7. Pregnant/lactating female 8. History of bladder disease and/or haematuria or has current haematuria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Changes in Alanine aminotransferase/Aspartate aminotransferase at 6 months would be assessed. -Change in hepatic steatosis grade (CAP)/Liver stiffness measurement (LSM) at 6 months would be assessed. -Change in the NAFLD fibrosis score from the initiation of treatment and at end of 6 months would be assessed. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in glycaemic parameters including glycosylated haemoglobin level (amount of glucose attached to haemoglobin) from baseline and at 6 months. -Improvement in lipidomic parameters like triglycerides, HDL, LDL, total cholesterol at 6 months. Timepoint: 6months | — |
Countries
India
Contacts
Public ContactBILAL AHMAD MIR
Indira gandhi medical college-shimla
Outcome results
None listed