Health Condition 1: - Health Condition 2: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Saroglitazar and Vitamin E: Group B - oral Saroglitazar 4mg OD and oral Vitamin E 400mg OD for 6 months
Control Intervention1: Saroglitazar: Group A - oral Saroglitazar 4mg OD for 6 mon
Sponsors
Pt BD Sharma PGIMS Rohtak
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in transient elastography score 2. Resolution of fatty liver on USG abdomen 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
| Measure | Time frame |
|---|---|
| 1. Change in body mass index 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. | — |
Countries
India
Contacts
Public ContactDr Pankaj Kaushik
Pt. B.D.Sharma PGIMS, Rohtak
Outcome results
None listed