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

Not Applicable

Recruiting

Conditions: Fatty (change of) liver, not elsewhere classified,

Registration Number: CTRI/2023/10/059025

Lead Sponsor: DINESH KUMAR

Brief Summary: A multicentric, prospective open-labeled trial to assess the efficacy and safety of Saroglitazaar magnesium 4mg along with Standard of Care in treating Metabolic Associated Steatosis Liver Disease. A 6-month prospective study will be done on persons diagnosed with metabolic-associated Steatotic liver disease also called as nonalcoholic fatty liver disease using Velocity controlled transient elastography also called Fibroscan. The persons having Steatosis stage 3 or fibrosis stage 2 or more will be prescribed the study drug and followed up for 6 months. The primary objective of the study is to see the efficacy of the drug in these patients and the secondary objective is to see the change in glycemic parameters, lipid parameters, and liver function test. We would also keep a watch on the adverse events, if any, associated with the drug.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

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

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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	1 month , 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
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).	6 months

Trial Locations

Locations (4): Chandra Diabetes and Heart Clinic
🇮🇳
Lucknow, UTTAR PRADESH, India
Harsha Clinic and Diabetes Centre
🇮🇳
Lucknow, UTTAR PRADESH, India
Prarthana Clinic and Diabetes Care Center
🇮🇳
Lucknow, UTTAR PRADESH, India
Udyan Health Centre Pvt Ltd
🇮🇳
Lucknow, UTTAR PRADESH, India
Chandra Diabetes and Heart Clinic
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Kumar Praful Chandra
Principal investigator
7800992222
drkpchandra@gmail.com