Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Vitamin E: Vitamin E (400 mg) twice a day for 2-years along with standard medical therapy (SMT)
Control Intervention1: Standard medical therapy: Standard medical therapy will include li
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients with NASH-related compensated cirrhosis belonging to CTP class A
Exclusion criteria
Exclusion criteria: 1. Patients who decline to give consent. 2. Patients who are non-cirrhotic or have advanced fibrosis only. 3. Patients with current or past history of decompensation(s) (clinical jaundice, ascites, hepatic encephalopathy, and portal hypertension related bleeding). 4. Patients belonging to CTP class B or C. 5. Patients presenting with acute-on-chronic liver failure (ACLF)[30]. 6. Patients with present or past clinical or imaging evidence of hepatocellular carcinoma/other malignancy(s). 7. Patients with present or past available data suggestive of any other competing or confounding etiologies for underlying cirrhosis. 8. Patients with severe cardio-pulmonary disease defined as NYHA class more than II, EF 9. Patient with severe renal insufficiency (eGFR 10. Patients on metformin, pioglitazone, liraglutide, saroglitazar or any other experimental/off-label treatment for NAFLD/NASH. 11. Patients who are pregnant or planning conception or are lactating. 12. Patients in whom FibroScan�® evaluation fails.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development new onset hepatic decompensations in patients with NASH-related compensated cirrhosis Timepoint: Follow up every 3months for 2 years post enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Development of HCCTimepoint: 2-years;Transplant-free survivalTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Arka De
PGIMER
Outcome results
None listed