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Role of anti cholesterol medicine for fatty liver

A PLACEBO CONTROLLED DOUBLE BLIND RANDOMIZED CONTROL STUDY TO EVALUATE THE EFFECT OF VITAMIN E AND SAROGLITAZAR IN LEAN NASH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049958
Enrollment
100
Registered
2023-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

Intervention1: Vitamin E and saroglitazar: Vitamin E 400mg Twice daily and Saroglitazar 4 mg once daily for 12 months Control Intervention1: Vitamin E and Placebo: Vitamin E 400mg Twice daily and Saro

Sponsors

AIG Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age > 18 Years BMI Patient with fatty liver disease, chronic liver disease without ascites (Child Pugh score <8)

Exclusion criteria

Exclusion criteria: Decompensated cirrhosis Allergy to Vitamin E or SAROGLITAZAR BMI > 23 kg/m2

Design outcomes

Primary

MeasureTime frame
Change in liver stiffness measurement using transient elastography in patients in each groupTimepoint: 0,6 and 12 months—

Secondary

MeasureTime frame
to assess change in controlled attenuation parameter in each groupTimepoint: 0,6 and 12 months;to assess change in liver function testsTimepoint: 0,6 and 12 months;to assess the change in HOMA-IR score in each groupsTimepoint: 0,6 and 12 months;to assess the change in Lipid profile in each groupTimepoint: 0,6 and 12 months—

Countries

India

Contacts

Public ContactAnand V Kulkarni

AIG Hospitals

dranand.v@aighospitals.com

Outcome results

None listed

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