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

Primary Purpose

Hepatitis, Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
N Acetylcysteine
Sponsored by
National Research Institute of Tuberculosis and Lung Disease, Iran
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Research Institute of Tuberculosis and Lung Disease (NRITLD)

Outcomes

Primary Outcome Measures

Hepatotoxicity

Secondary Outcome Measures

Full Information

First Posted
November 27, 2007
Last Updated
April 21, 2009
Sponsor
National Research Institute of Tuberculosis and Lung Disease, Iran
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1. Study Identification

Unique Protocol Identification Number
NCT00564642
Brief Title
Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity
Official Title
Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Research Institute of Tuberculosis and Lung Disease, Iran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Tuberculosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
N Acetylcysteine
Other Intervention Name(s)
ACC
Intervention Description
1200 mg, BD, 2weeks
Primary Outcome Measure Information:
Title
Hepatotoxicity
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shadi Baniasadi, PhD
Organizational Affiliation
National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Institute of Tuberculosis and Lung Disease (NRITLD)
City
Tehran
ZIP/Postal Code
19556
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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