To find out effect and safety of drug saroglitazar alone and in combination with vitamin E in patients having non alcoholic fatty deposition in liver
Not Applicable
- Conditions
- Health Condition 1: - Health Condition 2: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2021/07/034946
- Lead Sponsor
- Pt BD Sharma PGIMS Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients 18-70 years of age of either gender
2. Patients having alanine aminotransferase > 2 times of upper limit of normal (80-100 U/L) and ultrasound abdomen showing fatty liver
3. Patients with non-significant history of alcohol ( <10 gram/day for females, <20 gram/day for males), negative viral markers.
Exclusion Criteria
1. Patients with chronic liver disease other than non-alcoholic steatohepatitis
2. Patients with chronic kidney diseases
3. Patients with ischemic heart disease
4. Patients with cerebrovascular disease
5. Patients with chronic obstructive pulmonary disease
6. Prior exposure to saroglitazar
7. Patients with hepatocellular carcinoma
8. Pregnant females
9. Conjugated hyperbilirubinemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Improvement in transient elastography score <br/ ><br>2. Resolution of fatty liver on USG abdomen <br/ ><br>3. Improvement in liver enzymes (SGOT and SGPT)Timepoint: The patients will be assessed for the drug response at the end of 3 and 6 months. Any adverse drug reaction if occurs at any point in the study, has to be reported promptly and ADR monitoring to be done throughout the study.
- Secondary Outcome Measures
Name Time Method 1. Change in body mass index <br/ ><br>2. Change in lipid profile(improvement in triglycerides and cholesterol level)Timepoint: The patients will be assessed for the drug response at the end of 3 and 6 months.