Saroglitazar and Vitamin E are both being extensively used in India for non alcoholic fatty liver disease, though none of these drugs are FDA approved for this indication.However they are backed up by number of studies which shows improvement in liver function , reduction in NAS score. However, there is no head to head trial , nor is there any study with a paired biopsy comparing two arms for a head to head study. We therefore designed this study to see the effect of Vitamin E vs Vitamin E plus saroglitazar vs Saroglitazar alone when compared to standard dietary and weight loss treatment for NAFLD with raised ALT levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Patient receives Saraglitazar 4mg once daily
Patient receive Vitamin E 400mg twice daily after food for 6 months
Patient receives Vitamine E 400mg twice daily and Saraglitazar 4 mg once daily for 6 months
Patients receives dietary advise and does exercise in form of aerobic and targets 7 to 10 percent weight loss in 6 months
Asian Institute of Gastroenterology Hospitals
Hyderabad, Telangana, India
RECRUITINGChange in Non alcoholic fatty liver fibrosis score at 8week, 16week and 24week.
Non alcoholic fatty liver fibrosis score would be assessed . This is a non invasive test calculated by the formula : -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×109/l) - 0.66 × albumin (g/dl) Results are interpreted as : NAFLD Score \< -1.455 = F0-F2 NAFLD Score -1.455 - 0.675 = indeterminate score NAFLD Score \> 0.675 = F3-F4 Change in the NAFLD fibrosis score from the initiation of treatment and at end of 6 months would be assessed.
Time frame: 6 months
Serum Alanine aminotransferase (ALT) changes at 6 months.
Changes in Alanine aminotransferase at 6 months would be assessed.
Time frame: 6 months
Serum triglycerides (TG) level.
Improvement as evidenced by decrease in triglyceride at 6 months.
Time frame: 6 months
Change in fibrosis on Liver Biopsy at 6 months.
The study involves a paired liver biopsy and patients who undergo the second biopsy will be assessed for regression or decrease in fibrosis and steatosis score on biopsy. Score interpretation: Steatosis: \< 5%- 0, 5-33%- 1, \>33-66%- 2, \>66%- 3. Fibrosis: F0- No fibrosis, F1- Mild fibrosis, F2- Moderate fibrosis, F3- Severe fibrosis
Time frame: 6 months
Serum Aspartate aminotransferase (AST) level at 6 months.
Changes in Aspartate aminotransferase at 6 months would be assessed.
Time frame: 6 months
Non alcoholic steatosis (NAS) score on liver biopsy at 6 months.
Change in Non alcoholic Steatosis (NAS) score at 6 months. NAS score interpretation: Range- 0 to 8 ≥5- Non-alcoholic steatohepatitis (NASH)
Time frame: 6 months
Glycosylated Hemoglobin (HbA1C) Level at 6 months.
Change in glycosylated hemoglobin level (amount of glucose attached to hemoglobin) from baseline and at 6 months.
Time frame: 6 months
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