Drug trial between Dapagliflozin with existing drug Saroglitazar in patients with Non alcoholic fatty liver disease and diabetes
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Registration Number
- CTRI/2023/12/060736
- Lead Sponsor
- Deepthi v
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients with NAFLD diagnosed on ultrasonography
2.HbA1C >6.5%
3.BMI >25
4.Willingness to comply with all protocol required evaluations
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method