| CTRI Number |
CTRI/2025/10/096687 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of lipid lowering drugs on fatty liver disease with fibrosis |
|
Scientific Title of Study
|
Efficacy of rosuvastatin plus saroglitazar versus saroglitazar alone in patients of MASLD (ROSARO TRIAL) |
| Trial Acronym |
ROSARO TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajay kumar Mishra |
| Designation |
Assistant professor |
| Affiliation |
SGPGI Lucknow |
| Address |
Dept of hepatology, SGPGIMS Lucknow
LTU building 5 th floor
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9532870267 |
| Fax |
|
| Email |
ajaymishrapandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajay kumar Mishra |
| Designation |
Assistant professor |
| Affiliation |
SGPGI Lucknow |
| Address |
Dept of hepatology , SGPGIMS Lucknow
LTU building , 5th floor
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9532870267 |
| Fax |
|
| Email |
ajaymishrapandit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajay kumar Mishra |
| Designation |
Assistant professor |
| Affiliation |
SGPGI Lucknow |
| Address |
Dept of hepatology, SGPGIMS Lucknow
LTU 5th floor
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9532870267 |
| Fax |
|
| Email |
ajaymishrapandit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay gandhi post-graduate institute of medical sciences, Raibareli road Lucknow, Uttar Pradesh, India
226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi post graduate institute of medical sciences |
| Address |
Sanjay Gandhi post graduate institute of medical sciences,lucknow,Uttar Pradesh, India. PIN:226014 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay kumar Mishra |
SGPGI lucknow |
Sanjay gandhi postgraduate institute of medical sciences, Raibareli road Lucknow, Uttar Pradesh, India .PIN:226014
Lucknow
UTTAR PRADESH |
9532870267
ajaymishrapandit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGPGI Institute ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rosuvastatin 10mg once daily plus Saroglitazar 4 mg once daily |
The intervention to be given for 52 weeks |
| Comparator Agent |
Saroglitazar |
Saroglitazar 4mg once daily for 52 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults with MASLD with Liver stiffness 8 to 20 Spa |
|
| ExclusionCriteria |
| Details |
Hepatitis B or C, Significant alcohol intake, Patients on vitamin E or saroglitazar, Cirrhosis, malignancy,Pregnancy,lactation, uncontrolled diabetes, patients on statin for cardiovascular disease,Inability to perform fibroscan |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare mean reduction in liver stiffness values after 24 weeks of intervention |
To compare mean reduction in liver stiffness values after 24 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare mean reduction in liver stiffness at 52 weeks, Proportion of patients achieving decrease in at least one grade of fibrosis, Mean reduction in steatosis measured by FibroScan, Mean improvement in AST, ALT, LDL, Triglyceride, HDL, VLDL, fasting blood sugar and HOMA IR at 24 weeks, Changes in cytokeratin-18 and TNF alpha at 24 and 52 weeks of intervention |
24 weeks and 52 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients with advanced fibrosis defined by liver stiffness more than 8 Kpa to 20Kpa will be enrolled and randomised to either saroglitazar or combination of saroglitazar with rosuvastatin. Primary objective is to compare improvement in liver stiffness over 24 weeks. Secondary objective is to compare improvement in liver stiffness at 52 weeks. Also changes in lipid profile and other metabolic parameters will be compared at similar timeline. blood samples will be collected and evaluated for changes in cytokeratin-18 for studying changes in hepatic inflammation. |