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Efficacy and safety of saroglitazar and Vitamin E In Non alcoholic fatty liver related chronic liver disease.

Efficacy and Safety of Saroglitazar and Vitamin E in NAFLD Related Compensated Advanced Chronic Liver Disease. - Not applicable

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061701
Enrollment
60
Registered
2024-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: DRUG TRIAL SAROGLITAZOR VS VITAMIN E NAFLD related cACLD: patient with NAFLD related cACLD are given saroglitazor and VITAMIN E along with life style modification Intervention2: Sarogl

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age18-75years 2. Patients with NAFLD: Defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of FibroScan) in absence significant consumption of alcohol ( 3. Patients with LSM > 10kPa 4. Consent to participate in study

Exclusion criteria

Exclusion criteria: 1. Patients 2. Patients with Hepatic decompensation 3. Patients with HCC or any other malignancy 4. Patients with concomitant other aetiologies for hepatic steatosis/fibrosis or elevated transaminases 5. Patients already on Vitamin E or pioglitazone 6. Pregnancy/Lactation and those non pregnant female patients recruited in the study who will conceive during the study period will be excluded from the study. 7. Patients who are too sick to conduct the protocol. 8. Those who do not consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
Primary Outcomes: Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months. Timepoint: Primary Outcomes: Improvement in the hepatic fibrosis in patients with NAFLD related compensated advanced chronic liver disease at the end of 6 months.

Secondary

MeasureTime frame
Improvement in Hepatic fat fraction Improvement in MRE Improvement in FAST and MAST scores Improvemnt in ALT Improvement in Agaile 3+ and Agile 4 scoreTimepoint: at the end of 6 months

Countries

India

Contacts

Public ContactGANESH C P

PGIMER Chandigarh

hepatologyhod@gmail.com9884214626

Outcome results

None listed

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