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Efficacy of N-Acetyl cystein in prevention of drug induced hepatitis in tuberculosis patient

Protocol summary

Summary
The main objective of this study is performance measurement of N - acetylcysteine in prevention of liver toxicity due to anti-TB drugs. The population of study are 60 patients receiving anti-tuberculosis drugs that randomly divided into two groups of 30. During the duration of treatment with anti-tuberculosis drugs, the intervention group, are receiving of acetylcysteine 600 mg orally twice daily for a month and control groups, placebo, 600 mg orally twice per day. Demographic data, primary diagnosis, associated diseases and other medications patients are registered. Blood samples at baseline (before starting anti-TB drugs) and then weekly during the first month of the treatment with anti-TB drugs. Test for liver function (liver enzymes and, if necessary, bilirubin), ESR, CRP is measured. Also using the General Health Assessment Questionnaire (28GHQ) the status of general health in the two groups before and at the end of the first month will be compared. Inclusion criteria: age over 50 years; hemodynamic stability (mean arterial blood pressure >70 mmHg or systolic blood pressure >90mmHg ) Exclusion criteria: history of acute or chronic renal and liver failure accordance with the definitions of relevant, Unavailability of information related to liver function in basic mode, use of N- acetylcysteine orally, injected or inhaled during 1 month before the beginning of the study; Experience has confirmed that the incidence of hypersensitivity reactions following oral, intravenous or inhaled N- acetylcysteine; receiving concomitant drugs or compounds with antioxidant effects such as vitamin C, vitamin E; HIV + patients; use of alcohol

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205259855N1
Registration date: 2012-09-08, 1391/06/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-08, 1391/06/18
Registrant information
Name
Aiasghar Farazi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 6526
Email address
dr.farazi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-09-05, 1391/06/15
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of N-Acetyl cystein in prevention of drug induced hepatitis in tuberculosis patient
Public title
use of acetyl cystein in prevention of anti-TB drug induced hepatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age over 50 years; hemodynamic stability (mean arterial blood pressure >70 mmHg or systolic blood pressure >90mmHg ) Exclusion criteria: history of acute or chronic renal and liver failure accordance with the definitions of relevant, Unavailability of information related to liver function in basic mode, use of N- acetylcysteine orally, injected or inhaled during 1 month before the beginning of the study; Experience has confirmed that the incidence of hypersensitivity reactions following oral, intravenous or inhaled N- acetylcysteine; receiving concomitant drugs or compounds with antioxidant effects such as vitamin C, vitamin E; HIV + patients; use of alcohol
Age
From 50 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alam -al-hoda st. ,Arak , Iran
City
Arak
Postal code
Approval date
2012-07-23, 1391/05/02
Ethics committee reference number
15-128-91

Health conditions studied

1

Description of health condition studied
drug induced hepatits
ICD-10 code
K71.1
ICD-10 code description
Toxic liver disease with hepatic necrosis

Primary outcomes

1

Description
liver enzym and if necessary bilirubin
Timepoint
start of treatment and end of first , second, third and fourth of treatment
Method of measurement
paraclinic measurement and clinical interview

Secondary outcomes

1

Description
decrease of ESR and CRP
Timepoint
start of tretment and end of first , second,third , fourth of tretment
Method of measurement
lESR and CRP measurement

Intervention groups

1

Description
in case group patients take anti TB drugs and 600 mg / BID of n-acetyl cystein for one month
Category
Prevention

2

Description
in control group patients take anti-tb drugs and 600 mg / BID of placebo for one month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hos. and Emam reza clinic in Arak city
Full name of responsible person
Dr.aliasghar farazi
Street address
City
Aarak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical sciences
Full name of responsible person
Dr.hekmatpoo
Street address
Rrecearch manager,sardasht st. ,arak,iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.aliasghar farazi
Position
Assistant professor
Other areas of specialty/work
Street address
Infectious diseases ward,Valiasr hos. , Arak , Iran
City
arak
Postal code
Phone
+98 86 1223 6855
Fax
+98 86 1224 2411
Email
dr.farazi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.aliasghar farazi
Position
Assistant professor
Other areas of specialty/work
Street address
Valiasr hospital,Arak,Iran
City
Arak
Postal code
Phone
+98 86 1223 6855
Fax
Email
dr.farazi@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.aliasghar farazi
Position
Assistant professor
Other areas of specialty/work
Street address
Infectious diseases ward,Valiasr hospital,Arak Iran
City
Arak
Postal code
Phone
+98 86 1223 6855
Fax
Email
dr.farazi@arakmu.ac.irfarazialiasghar@yahoo.comfarazialiasghar22@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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