To study the effect of rosuvastatin in addition to lifestyle modification in patients of fatty liver disease

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 - RSFLD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100241

Enrollment

Registered

2026-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K70-K77- Diseases of liver

Interventions

Intervention1: Rosuvastatin 10mg: Patients of metabolic dysfunction-associated fatty liver disease will be given rosuvastatin 10 mg along with lifestyle modifications Control Intervention1: Lifestyl

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of adjunct rosuvastatin versus lifestyle modification alone on mean changes from baseline in liver function tests by week 12Timepoint: Visit 1 Baseline Visit 2 6 weeks after enrollment Visit 3 12 weeks after enrollment	—

Secondary

Measure	Time frame
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. Timepoint: Visit 1 Baseline Visit 2 6 weeks after enrollment Visit 3 12 weeks after enrollment	—

Measure

Time frame

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. Timepoint: Visit 1 Baseline Visit 2 6 weeks after enrollment Visit 3 12 weeks after enrollment

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Countries

India

Contacts

Public ContactDr Amrit Kaur

Government Medical College, Patiala

drnavjotpharma@gmail.com9478610997

Outcome results

None listed

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