Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Saroglitazar: Saroglitazar (4 mg/day) along with standard medical therapy for 6-months
Control Intervention1: Standard medical therapy: Standard medical therapy consisting of lifestyle
Sponsors
PGIMER CHANDIGARH
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Patients with BMI â?¥ 25 kg/m2, age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in hepatic steatosis as evidenced by CAP at 6 monthsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in steatohepatitis as evidenced by FibroScan-AST score (FAST) score at 6 months 2. Improvement in hepatic fibrosis at 6 months by non-invasive parameters [Liver stiffness measurement(LSM), AST to Platelet Ratio (APRI), FIB4] 3. Improvement in ALT (in those with baseline elevated ALT) 4. Change in glycemic profile at 6 months by HbA1c 5. Change in Lipid profile 6. Adverse effects of saroglitazar using CTCAE version 5 7. Change in anthropometric parameters[Body weight, Body Mass Index(BMI) and abdominal circumference] 8. Change in insulin resistance as assessed by HOMA â?? IR 9. Improvement in the Quality of life assessed through CLDQ QuestionnaireTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactNaveen Bhagat
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed