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临床试验/NCT00564642
NCT00564642已完成不适用

Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

National Research Institute of Tuberculosis and Lung Disease, Iran2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2007年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Hepatotoxicity

研究概览

简要总结

Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in developing countries compared to that in advanced countries with a similar dose schedule. Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis drugs induced hepatic injury. The oxidative stress is closely associated with decrease of glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Two sputum specimens positives for tubercle bacilli on direct smear microscopy
  • No previous anti-TB chemotherapy higher than two weeks
  • Aged 60 years and over
  • Agreement to participate in the study

排除标准

  • Alcohol consumption
  • Viral disease (Hepatitis,...)
  • Abnormal pretreatment LFT level
  • Chronic disease (liver and kidney disease, asthma,...)
  • Additional hepatotoxic drug use
  • HIV positive
  • Patient in a moribund state
  • Hemoptysis

结局指标

主要结局

Hepatotoxicity

时间窗: Two weeks

次要结局

未报告次要终点

研究者

发起方
National Research Institute of Tuberculosis and Lung Disease, Iran
申办方类型
Other Gov

研究点 (2)

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