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临床试验/CTRI/2022/09/045688
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

Postgraduate Institute of Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募

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.

研究者

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