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

NCT ID: NCT00564642

Last Updated: 2009-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-04-30

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.

Conditions

Hepatitis; Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

N Acetylcysteine

1200 mg, BD, 2weeks

Intervention Type: DRUG

Other Intervention Names

ACC

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Institute of Tuberculosis and Lung Disease, Iran

OTHER_GOV

Sponsor Role: lead

Responsible Party

National Research Institute of Tuberculosis and Lung Disease

Principal Investigators

Shadi Baniasadi, PhD

Role: PRINCIPAL_INVESTIGATOR

National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences

Locations

National Research Institute of Tuberculosis and Lung Disease (NRITLD)

Tehran, , Iran

Countries

Iran

Other Identifiers

5344-21-07-86

Identifier Type: -

Identifier Source: org_study_id