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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Key information

Conditions

Hepatitis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Gram-Positive Bacterial Infections Infections Liver Diseases Mycobacterium Infections Tuberculosis

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Institute of Tuberculosis and Lung Disease (NRITLD)

Tehran, 19556, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N Acetylcysteine

Drug

1200 mg, BD, 2weeks

Other names: ACC

Primary outcomes

Hepatotoxicity

Time frame: Two weeks

Sponsors and collaborators

Lead sponsor

National Research Institute of Tuberculosis and Lung Disease, Iran

Other Gov

Registry information

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Nov 28, 2007
Registry last updated: Apr 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed