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

National Research Institute of Tuberculosis and Lung Disease, Iran

Status: Completed

Conditions: Tuberculosis; Hepatitis

Treatments: Drug: N Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT00564642

5344-21-07-86

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)