| CTRI Number |
CTRI/2026/01/100241 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of rosuvastatin in addition to lifestyle modification in patients of fatty liver disease |
|
Scientific Title of Study
|
Assessment of efficacy and safety of rosuvastatin as an adjunct to lifestyle modification in patients of metabolic dysfunction-associated-fatty liver disease (MAFLD): a prospective randomised controlled trial |
| Trial Acronym |
RSFLD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrit Kaur |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College , Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9888613977 |
| Fax |
|
| Email |
dr.amrit2111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navjot Kaur |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9478610997 |
| Fax |
|
| Email |
drnavjotpharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrit Kaur |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab
Patiala
PUNJAB
147001
India |
| Phone |
9888613977 |
| Fax |
|
| Email |
dr.amrit2111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Patiala |
|
|
Primary Sponsor
|
| Name |
Government Medical College Patiala |
| Address |
Government Medical College, Patiala, Punjab, 147001 |
| 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 Amrit Kaur |
Rajindra Hospital Patiala |
OPD Department of Medicine unit 3 room no 1
Patiala
PUNJAB |
9888613977
dr.amrit2111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee( IEC) Government Medical College Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K70-K77||Diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lifestyle modification |
Patients of metabolic dysfunction-associated fatty liver disease will be advised lifestyle modifications only |
| Intervention |
Rosuvastatin 10mg |
Patients of metabolic dysfunction-associated fatty liver disease will be given rosuvastatin 10 mg along with lifestyle modifications
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults of either gender in the age group of 18-65 years
2.Patients with confirmed diagnoses of MAFLD
3.Patient suffering from obesity, dyslipidemia, hypertension and hypercholestronemia (Metabolic syndrome).
4.Patients who provide written informed consent for study participation
|
|
| ExclusionCriteria |
| Details |
1.Individuals with known causes of liver injury such as viral hepatitis, autoimmune liver disease etc.
2.Patients taking excessive alcohol. (Male more than 21drinks per week Female more than 14 drinks weeks per week)
3.History of any drug abuse
4.Pregnant and lactating women
5.Patient already on statins treatment
6.Patient with known contraindications to rosuvastatin
|
|
|
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 the efficacy of adjunct rosuvastatin versus lifestyle modification alone on mean changes from baseline in liver function tests by week 12 |
Visit 1 Baseline
Visit 2 6 weeks after enrollment
Visit 3 12 weeks after enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare efficacy of adjunct rosuvastatin versus lifestyle modification alone on mean changes from baseline in CAP score at week 12.
2. To compare efficacy of adjunct rosuvastatin versus lifestyle modification alone on mean changes from baseline in lipid profile parameters (i.e. Total Cholesterol, Triglycerides, LDL and HDL).
3. To compare proportion of individuals showing improvement in steatosis grade compared to baseline among the study groups.
4. To assess the safety of adjunct rosuvastatin versus lifestyle modification by comparing adverse events among the study groups.
|
Visit 1 Baseline
Visit 2 6 weeks after enrollment
Visit 3 12 weeks after enrollment |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
14/01/2026 |
| 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="1"
Months="0"
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
|
MAFLD (Metabolic dysfunction- associated fatty liver disease) is one of the most common chronic liver disease affecting 32.4% of the global population. MAFLD is defined as a liver disorder caused by accumulation of excess fat (>5%) in liver cells also known as steatosis or fatty liver, which is not necessarily caused by significant alcohol consumption.MAFLD is closely related with obesity, type 2 diabetes mellitus, dyslipidemia, hypertension, coronary artery disease, metabolic syndrome etc. MAFLD includes a spectrum of conditions ranging from simple hepatic steatosis to non-alcoholic steatohepatitis (NASH), which can progress to liver fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma (HCC).While efforts have made to develop effective treatment for MAFLD but the need of pharmaceutical interventions still remains unmet. Currently standard of care only includes lifestyle modification such as healthy diet, regular physicial activity, weight loss, reduced free sugars etc. Pharmacological interventions are still under development and there is no specific medication that has been approved as a standard treatment. statins in addition to hypolipidemic effects,have other pleiotropic effects including anti thrombotic, antifibrotic and anti-inflammatory properties. These properties make statins potentially useful in preventing the progression of MAFLD to more severe forms like steatohepatitis, cirrhosis .Recent studies across the globe have found statins to be useful in causing reduction in liver fat , improvement in liver function tests indicating improvement in liver function. |