Efficacy and safety of saroglitazar and Vitamin E In Non alcoholic fatty liver related chronic liver disease.
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Registration Number
- CTRI/2024/01/061701
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age18-75years
2.Patients with 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 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.
3.Patients with LSM > 10kPa
4.Consent to participate in study
1.Patients <18years of age
2.Patients with Hepatic decompensation
3.Patients with HCC or any other malignancy
4.Patients with concomitant other aetiologies for hepatic steatosis/fibrosis or elevated transaminases
5.Patients already on Vitamin E or pioglitazone
6.Pregnancy/Lactation and those non pregnant female patients recruited in the study who will conceive during the study period will be excluded from the study.
7.Patients who are too sick to conduct the protocol.
8.Those who do not consent to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcomes: <br/ ><br> <br/ ><br>Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months. <br/ ><br>Timepoint: Primary Outcomes: <br/ ><br> <br/ ><br>Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Improvement in Hepatic fat fraction <br/ ><br>Improvement in MRE <br/ ><br>Improvement in FAST and MAST scores <br/ ><br>Improvemnt in ALT <br/ ><br>Improvement in Agaile 3+ and Agile 4 scoreTimepoint: at the end of 6 months