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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564642
• Other study ID #: 5344-21-07-86
• Status: Completed
• Phase: N/A
• First received: November 27, 2007
• Last updated: April 21, 2009
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: National Research Institute of Tuberculosis and Lung Disease, Iran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Tuberculosis

Intervention

Drug:
• N Acetylcysteine
1200 mg, BD, 2weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Research Institute of Tuberculosis and Lung Disease (NRITLD)	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Research Institute of Tuberculosis and Lung Disease, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatotoxicity		Two weeks	No