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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00564642
Other study ID # 5344-21-07-86
Secondary ID
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


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
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