A randomized study to compare role of saroglitazar, vitamin E and life style modification in treatment of non-alcoholic fatty liver disease
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2022/05/042462
- Lead Sponsor
- Anurag Kumar Tiwari
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients with non alcoholic fatty liver disease/ non alcoholic steatohepatitis who will demonstrate understanding of study requirements and treatment procedures, and willing to comply with all protocol-required evaluations.
Patients having alanine aminotransferase (ALT) elevation of at least 1.5 times of upper limit of normal and liver stiffness measurement of more than 7 Kilo- pascals (KPa).
1.Present or past (within 2 year of inclusion) alcohol user >20g/day in males; >10g/day in females.
2.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis.
3.Patients with decompensated cirrhosis.
4.Patients with Thyroid disorders.
5.Pregnant and lactating females and females who are not willing to use contraception during study period.
6.Patients with diabetes mellitus, coronary artery disease, uncontrolled hypertension, chronic kidney disease or any chronic systemic illness that in view of investigator would make patient unsuitable for study.
7.Patients using alternative medicines or ursodeoxycholic acid, Sadenosylmethionine (SAM-e), betaine, pentoxifylline etc for NAFLD during last 1 month from inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method