Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Saroglitazar: 4 mg OD for 14 weeks
Intervention2: Dapagliflozin: 10 mg OD for 14 weeks
Control Intervention1: Saroglitazar: 4 mg OD for 14 weeks
Sponsors
Deepthi v
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with NAFLD diagnosed on ultrasonography 2.HbA1C >6.5% 3.BMI >25 4.Willingness to comply with all protocol required evaluations
Exclusion criteria
Exclusion criteria: 1.Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.). 2. Average alcohol consumption greater than equal to 21 drinks per week formen, greater than equal to 14 drinks per week for women in the 6 months before enrollment. 3.The patients who already used medications known to cause hepatic steatosis for more than two weeks in the past year such as mipomersen, lomitapide, amiodarone, methotrexate, tamoxifen, corticosteroid, valproate, antiretroviral medicines. 4.Presence of alternative cause of fatty liver, including Total Parenteral Nutrition, Starvation, Lipodystrophy, -Abetalipoproteinemia, Acute fatty liver of pregnancy, HELLP syndrome, Reye’s syndrome. Clinical, imaging, or histological evidence of cirrhosis. 5.Use of drugs with a potential effect on NASH such as ursodeoxycholic acid, vitamin E, pioglitazone. 6.Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NAFLD fibrosis scoreTimepoint: 0,14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| AST,ALTTimepoint: 0,14 weeks;Liver shear wave elastographyTimepoint: 0,14 weeks;Serum lipid profileTimepoint: 0,14 weeks | — |
Countries
India
Contacts
Public ContactDr Deepthi V
Saveetha medical college
Outcome results
None listed