Saroglitazar as monotherapy versus Saroglitazar plus Vitamin E combination therapy in management of Non Alcoholic Fatty Liver Disease

Phase 4

Not yet recruiting

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

• Registration Number: CTRI/2023/10/058636
• Lead Sponsor: MGM Medical College and Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients having Fatty Liver Grade 1 to 3 on USG

Ultrasound Attenuation Parameter more than 244 db./m.

Patients with F0 to F3 fibrosis on TE.

Individuals with BMI more than 23 kg per m2

Patient willing to participate in the study and give written informed consent

Exclusion Criteria

Patients with significant alcohol consumption per day.

Patients with BMI less than 23 kg/m2.

Pre-diabetic patients and patients with known history of lean NASH.

Patients having F4 fibrosis on TE.

Patients having chronic viral hepatitis B and C.

Patients having other chronic liver diseases.

Patients having thyroid dysfunction or any metabolic disorder, except diabetes.

Patients taking any concurrent medications known to affect liver enzymes or CBC.

Patients showing intolerance to Saroglitazar and Vitamin E.

Pregnant and Lactating women.

Patients not willing to participate in the study and give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iver fat content and fibrosis will be assessed at the end of the study i.e. at 12 monthsTimepoint: Visit 0 Baseline <br/ ><br>Visit 1 at 3 months <br/ ><br>Visit 2 at 6 months <br/ ><br>Visit 3 at 9 months <br/ ><br>End of therapy visit at 12 months

Secondary Outcome Measures

Name	Time	Method
To study the occurrence of adverse drug reactions to Vit E & SaroglitazarTimepoint: 2 years