A Study to assess the benefits and safety profile of the drug Saroglitazar in patients of non alcoholic fatty liver disease who are not obese(BMI less than 25)
- Conditions
- Health Condition 1: K00-K95- Diseases of the digestive systemHealth Condition 2: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2022/09/046081
- Lead Sponsor
- PGIMER CHANDIGARH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Patients with normal BMI ( >18 to < 25 kg/m2) diagnosed as NAFLD defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of FibroScan) in absence significant consumption of alcohol ( <20g/day) irrespective of gender after ruling out other etiologies of other etiologies for hepatic steatosis or elevated transaminases including but not limited to chronic viral hepatitis, autoimmune Hepatitis, hemochromatosis, Wilson disease, celiac disease, drug induced liver injury (DILI), etc. and having LSM <13.6 kPa
Patients with BMI >= 25 kg/m2, age <18 years or >75 years of age.
Patients with cirrhosis or with HCC or any other malignancy.
Patients with concomitant other etiologies for hepatic steatosis or elevated transaminases. Patients already on Vitamin E or pioglitazone.
Pregnant or lactating.
Patients too sick or not consenting to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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