CTRI/2022/09/045688尚未招募未知
Impact of Vitamin E (alpha-tocopherol) therapy on long-term outcomes in patients with Non-alcoholic steatohepatitis (NASH) related compensated cirrhosis: An open label, randomized control trial
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with NASH-related compensated cirrhosis belonging to CTP class A
排除标准
- •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 <40-45%, FEV1/FVC <60%.
- •9.Patient with severe renal insufficiency (eGFR < 30 ml/min/1.73 m2) or those requiring maintenance hemodialysis.
- •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 FibroScanÃ?® evaluation fails.
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