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

This study has been completed.
Sponsor:
Information provided by:
National Research Institute of Tuberculosis and Lung Disease, Iran
ClinicalTrials.gov Identifier:
NCT00564642
First received: November 27, 2007
Last updated: April 21, 2009
Last verified: April 2009
History of Changes

November 27, 2007
April 21, 2009
November 2007
January 2009   (final data collection date for primary outcome measure)
Hepatotoxicity [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Hepatotoxicity [ Time Frame: Two weeks ]
Complete list of historical versions of study NCT00564642 on ClinicalTrials.gov Archive Site
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Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity
Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

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.
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Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hepatitis
  • Tuberculosis
Drug: N Acetylcysteine
1200 mg, BD, 2weeks
Other Name: ACC
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Alcohol consumption
  • Viral disease (Hepatitis,...)
  • Abnormal pretreatment LFT level
  • Chronic disease (liver and kidney disease, asthma,...)
  • Additional hepatotoxic drug use
  • HIV positive
  • Liver TB
  • Patient in a moribund state
  • Hemoptysis
Both
60 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00564642
5344-21-07-86
Yes
Dr. Baniasadi, National Research Institute of Tuberculosis and Lung Disease
National Research Institute of Tuberculosis and Lung Disease, Iran
Not Provided
Principal Investigator: Shadi Baniasadi, PhD National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences
National Research Institute of Tuberculosis and Lung Disease, Iran
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP