A clinical trial to study the effects of two drugs,Saroglitazar and Vitamin E in patients with Non-Alcoholic fatty liver disease.

Phase 3

Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Registration Number: CTRI/2022/01/039538

Lead Sponsor: Bilal Ahmad Mir

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Confirmed Diagnosis of NAFLD established either by imaging or liver biopsy according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasaniet al.2017).

2.Adults ( >18years)

Exclusion Criteria

1.Absence of regular or excessive use of alcohol within 2 years prior to initial screening.

2.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis.

3.Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or Imaging techniques.

4.Patients with Hypothyroidism and celiac disease.

5. Presence of alternative causes of fatty liver, including:

Weight loss >10% in the 6 months before the Screening Visit

Total parenteral nutrition, starvation or protein-calorie malnutrition

Use of drugs associated with NAFLD.

6. History of malignancy in the past 5 years and/or active neoplasm

7. Pregnant/lactating female

8. History of bladder disease and/or haematuria or has current haematuria.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Changes in Alanine aminotransferase/Aspartate aminotransferase at 6 months would be assessed. <br/ ><br>-Change in hepatic steatosis grade (CAP)/Liver stiffness measurement (LSM) at 6 months would be assessed. <br/ ><br>-Change in the NAFLD fibrosis score from the initiation of treatment and at end of 6 months would be assessed. <br/ ><br>Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
-Change in glycaemic parameters including glycosylated haemoglobin level (amount of glucose attached to haemoglobin) from baseline and at 6 months. <br/ ><br>-Improvement in lipidomic parameters like triglycerides, HDL, LDL, total cholesterol at 6 months. <br/ ><br>Timepoint: 6months