A randomized study to compare role of saroglitazar, vitamin E and life style modification in treatment of non-alcoholic fatty liver disease

Prospective, Randomized Study of role of Saroglitazar, vitamin E and lifestyle modification in Patients with Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH)

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042462

Enrollment

180

Registered

2022-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Saroglitazar and life style modification: Saroglitazar 4 mg once daily, Per Oral plus daily exercise and dietary modification as advised by dietician for 6 months Intervention2: vitamin

Eligibility

Inclusion criteria

Inclusion criteria: Patients with non alcoholic fatty liver disease/ non alcoholic steatohepatitis who will demonstrate understanding of study requirements and treatment procedures, and willing to comply with all protocol-required evaluations. Patients having alanine aminotransferase (ALT) elevation of at least 1.5 times of upper limit of normal and liver stiffness measurement of more than 7 Kilo- pascals (KPa).

Exclusion criteria

Exclusion criteria: 1.Present or past (within 2 year of inclusion) alcohol user >20g/day in males; >10g/day in females. 2.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis. 3.Patients with decompensated cirrhosis. 4.Patients with Thyroid disorders. 5.Pregnant and lactating females and females who are not willing to use contraception during study period. 6.Patients with diabetes mellitus, coronary artery disease, uncontrolled hypertension, chronic kidney disease or any chronic systemic illness that in view of investigator would make patient unsuitable for study. 7.Patients using alternative medicines or ursodeoxycholic acid, Sadenosylmethionine (SAM-e), betaine, pentoxifylline etc for NAFLD during last 1 month from inclusion.

Design outcomes

Primary

Measure	Time frame
Primary: 1.Improvement or change in NAFLD fibrosis score at 6 months based on the calculation of Age, BMI, DM, AST/ALT ratio, platelet and albumin. 2. Liver stiffness measurement (LSM) change or improvement at 6 months. Secondary: improvement/change in Weight, Serum Aspartate aminotransferase (AST) level Serum Alanine aminotransferase (ALT) level, Serum triglycerides (TG) level, FIB-4 score (calculated using age, AST, ALT and platelet count), APRI index (AST to platelet ratio index) and Adverse events.Timepoint: 6 month	—

Measure

Time frame

Primary: 1.Improvement or change in NAFLD fibrosis score at 6 months based on the calculation of Age, BMI, DM, AST/ALT ratio, platelet and albumin. 2. Liver stiffness measurement (LSM) change or improvement at 6 months. Secondary: improvement/change in Weight, Serum Aspartate aminotransferase (AST) level Serum Alanine aminotransferase (ALT) level, Serum triglycerides (TG) level, FIB-4 score (calculated using age, AST, ALT and platelet count), APRI index (AST to platelet ratio index) and Adverse events.Timepoint: 6 month

—

Secondary

Measure	Time frame
Secondary: improvement/change in Weight, Serum Aspartate aminotransferase (AST) level Serum Alanine aminotransferase (ALT) level, Serum triglycerides (TG) level, FIB-4 score (calculated using age, AST, ALT and platelet count), APRI index (AST to platelet ratio index) and Adverse events.Timepoint: 6 months	—

Countries

India

Contacts

Public Contactanurag kumar tiwari

Institute of medical sciences, Banaras Hindu University

tiwarianuragk@gmail.com7800322490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026