Tuberculosis Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | National Research Institute of Tuberculosis and Lung Disease (NRITLD) | Tehran |
Lead Sponsor | Collaborator |
---|---|
National Research Institute of Tuberculosis and Lung Disease, Iran |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hepatotoxicity | Two weeks | No |
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