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CTRI Number  CTRI/2026/01/100723 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of the two drugs named Saroglitazaar Magnesium 4mg and Ursodeoxycholic acid for their effects on the liver fat and fibrosis in persons having diabetes and fatty liver 
Scientific Title of Study   A Multicentric, prospective, open-label clinical trial to assess the efficacy and safety of Saroglitazaar Magnesium 4mg along with the standard of care, in the treatment of hepatic steatosis and fibrosis, in comparison to Ursodeoxycholic acid along with standard of care, in people living with Type 2 Diabetes Mellitus and/or Metabolic dysfunction-associated steatotic liver disease. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DINESH KUMAR 
Designation  MBBS MD MEDICINE 
Affiliation  Harsha Clinic and Diabetes Centre 
Address  Room Number 1, Medicine Department, Harsha Clinic and Diabetes Centre, Puran Nagar, Kanpur Road
Not Applicable
Lucknow
UTTAR PRADESH
226012
India 
Phone  9839007147  
Fax    
Email  dineshharshaclinic@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DINESH KUMAR 
Designation  MBBS MD MEDICINE 
Affiliation  Harsha Clinic and Diabetes Centre 
Address  Harsha Clinic Diabetes Centre, Room Number 1, Medicine Department, Puran Nagar, Kanpur Road
Not Applicable
Lucknow
UTTAR PRADESH
226012
India 
Phone  9839007147  
Fax    
Email  dineshharshaclinic@gmail.com  
 
Details of Contact Person
Public Query  
Name  DINESH KUMAR 
Designation  MBBS MD MEDICINE 
Affiliation  Harsha Clinic and Diabetes Centre 
Address  Room Number 1, Medicine Department, Harsha Clinic and Diabetes Centre, Puran Nagar, Kanpur Road
Not applicable
Lucknow
UTTAR PRADESH
226012
India 
Phone  9839007147  
Fax    
Email  dineshharshaclinic@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DINESH KUMAR 
Address  Harsha Clinic and Diabetes Centre, Room Number 1, Medicine Department, Puran Nagar, Kanpur Road, Lucknow 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tuhina Gupta  Blossom Women & Chilgren Clinic  Room number 2, Gynecology Department, First floor, Suncity Avenue, 102, Sector 102
Gurgaon
HARYANA 		 8127454364

tuhinaemail@gmail.com 
Dr K P Chandra  Chandra Diabetes and Heart Clinic  D-4/658, Vijayant Khand Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH 		 7800992222

drkpchandra@gmail.com 
Dr Dinesh Kumar  Harsha Clinic and Diabetes Centre  Medicine Department, Room number 1, Puran Nagar, Kanpur Road
Lucknow
UTTAR PRADESH 		 7355389642

dineshharshaclinic@gmail.com 
Dr Rajiv Awasthi  Pratharna Clinic and Diabetes Care Centre  510,179, New Hyderabad, Hasan Ganj, Lucknow
Lucknow
UTTAR PRADESH 		 9838281506

prarthanaclinic@gmail.com 
Dr Mukulesh Gupta  Udyaan Health Care Pvt Ltd  Udyan1 Eldeco, Near Bangla Bazaar, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 9336046146

drmukulesh@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Human Ethics Committee Udyaan Healthcare  Approved 
Institutional Human Ethics Committee Udyaan Healthcare  Approved 
Institutional Human Ethics Committee Udyaan Healthcare  Approved 
Institutional Human Ethics Committee Udyaan Healthcare  Approved 
Institutional Human Ethics Committee Udyaan Healthcare  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Saroglitazar Magnesium 4mg   It is an 4mg oral tablet given , once daily before dinner, and will be given for 6 months 
Comparator Agent  Ursodeoxycholic acid  This is also an oral tablet and will be given in doses of 300mg three times daily after meals for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  People having Type 2 Diabetes Mellitus and /or at least one of the four parameters of Metabolic Syndrome: Hypertension ( or taking any drugs for hypertension ), obesity, high triglyceride ( or taking any medications for dyslipidemia), and low HDL.
A diagnosis of liver steatosis stage 3 (S3) and/or fibrosis ( F2F3F4) established by Vibration Controoled Transient Elastography using Fibroscan 
 
ExclusionCriteria 
Details  1. Having an established diagnosis of Cirrhosis
2. Person with T1DM
3. Person with greater than S3 steatosis if LSM is greater than 8kPa on VCTE
4. Person already on Thiazolidinediones, Vitamin E
5. A person taking alcohol in a quantity more than the standard limits set by AASLD (Asia Pacific region)
6. Person having positive HBsAg or anti-HCV
7. People on steatogenic drugs like amiodarone. Methotrexate, oral contraceptives, and steroids
8. People with other causes of liver disease, e.g., Wilsons Disease, Autoimmune Disease, alcoholic liver disease
9. Pregnant and lactating females
10. People with underlying diseases like acute viral hepatitis. congestive hepatomegaly, or biliary congestion, can disturb the estimation done by VCTE
11. Person having Hepatocellular Carcinoma
12. Person having a known allergy to saroglitazar
13. A person having any other severe illness that may render the follow-up difficult
14. Person not giving written consent for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective of the proposed study is to evaluate the efficacy of Saroglitazaar magnesium 4mg along with standard of care (SOC) on hepatic steatosis and fibrosis in comparison to ursodeoxycholic acid along with SOC in people living with T2DM and Metabolic dysfunction-associated steatotic liver disease (MASLD)  The participants will be assessed at baseline, then at 4 weeks, 12 weeks and finally at 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of saroglitazaar magnesium 4mg on blood glucose levels,blood lipid levels, liver function tests, compared to ursodeoxycholic acid   The participants will be assessed at baseline, 4 weeks, 12 weeks, & finally at 24 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Our study aims to compare the efficacy and safety of two drugs in the treatment of Metabolically Associated Steatotic Liver Disease (MASLD). One of the drugs is Saroglitazar Magnesium 4mg, which DCGI has already approved for use in MASLD. Another drug is ursodeoxycholic acid, which has not shown any significant improvement in the treatment of MASLD and is not recommended for MASLD by any organisation. It will be used as a comparator drug. The drugs will be used in patients of MASLD with Fibroscan reports showing either Grade 3 steatosis and/ or more than or equal to stage 2 fibrosis. The follow-up will last 6 months per protocol, and a repeat fibroscan will be performed at the end of the trial. The primary objective of the study is to assess improvements in liver steatosis and fibrosis based on the FibroScan report. The secondary aim will be to determine the effects of the drugs on liver function tests, lipid profile, glucose parameters, and platelet count. 
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