A study to see the effectiveness and safety of Saroglitazaar 4mg in persons with Nonalcoholic fatty liver disease

A Multicentric, Prospective, 0pen-labeled, clinical trial to assess the efficacy and safety of Saroglitazaar Magnesium 4mg along with standard of care (SOC), in the treatment of Metabolic Associated Steatotic Liver Disease (MASLD) - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/10/059025

Enrollment

100

Registered

2023-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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: Saroglitazaar Magnesium: 4mg Tablet, Once daily, orally at night before dinner for 6 months Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Age > 18 years Body Mass Index > 23kg/m2 Having at least 2 of the 5 parameters of Metabolic Syndrome: Hypertension or taking any drugs for hypertension, Diabetes or prediabetes or taking any drugs for diabetes, Obesity, High Triglyceride and low HDL

Exclusion criteria

Exclusion criteria: Established diagnosis of Cirrhosis Persons with T1DM A person already on Thiazolidinediones, Vitamin E. Persons taking alcohol in a quantity more than the standard limits set by AASLD (Asia PACIFIC region) Persons having positive HBsAg or anti-HCV Persons on steatogenic drugs like amiodarone, methotrexate, oral contraceptives, and steroids. Persons with other causes of liver disease e.g., Wilsons Disease, Autoimmune Disease, alcoholic liver disease Pregnant and Lactating females Persons having an underlying disease like acute viral hepatitis, congestive hepatomegaly, or biliary congestion can disturb the estimation done by VCTE. Persons having known allergy to saroglitazaar Persons having any other severe illness which may render the follow-up difficult Persons not giving written consent for the study

Design outcomes

Primary

Measure	Time frame
The primary objective of the proposed study is to evaluate the efficacy and safety of Saroglitazaar magnesium 4mg along with standard of care (SOC) in the treatment of Metabolic Associated Steatotic Liver Disease (MASLD)Timepoint: 1 month , 3 months and 6 months	—

Secondary

Measure	Time frame
The secondary objective of the proposed study is to evaluate the efficacy of Saroglitazaar magnesium 4mg on blood glucose levels, blood lipid levels and liver function tests (LFT).Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDINESH KUMAR

Harsha Clinic and Diabetes Centre

dineshharshaclinic@gmail.com9839007147

Outcome results

None listed

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