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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00564642
Enrollment
60
Registered
2007-11-28
Start date
2007-11-30
Completion date
2009-04-30
Last updated
2009-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis, Tuberculosis

Brief summary

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.

Interventions

1200 mg, BD, 2weeks

Sponsors

National Research Institute of Tuberculosis and Lung Disease, Iran
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
HepatotoxicityTwo weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026