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Randomized, Double-Blind, Placebo-Controlled Trial of L-Arginine Supplementation for the treatment of pulmonary Tuberculosis

Protocol summary

Summary
This study aimed to assess the efficacy of L-arginine supplementation for treatment of pulmonary tuberculosis, that designed as a randomized, double-blind, placebo-controlled trial.In this study, 60 new smear positive patients (30 patients in the case group, 30 patients in the control group), of 10 health care centers in Central Province randomly are selected and After obtaining informed consent , patients randomly will be divided into two groups, in case group is givenThe standard treatment of TB with L - arginine (2 g per day for 30 days)and in Control group , along with standard TB treatment is given placebo(2 g per day for 30 days). Baseline clinical evaluation of all patients before the plan is Including chest radiography, weight measurement, and check of CBC, ESR, and CRP.The Patients at days 14, 28, 42 and 56 after treatment are followed. the collected data analyzed by spss( version 19) software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211179855N2
Registration date: 2013-01-10, 1391/10/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-01-10, 1391/10/21
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
2012-12-21, 1391/10/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, Double-Blind, Placebo-Controlled Trial of L-Arginine Supplementation for the treatment of pulmonary Tuberculosis
Public title
Effectivenessof L-Arginine supplementation for treatment of patients with pulmonary tuberculosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adults over 15 years ;New cases of positive sputum smear Exclusion criteria: pregnant women ; aged under 15 years, ;patients who During the past month received L-arginine ; Sensitivity to L - arginine
Age
From 15 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Alam al hoda street , Arak , Iran
City
Arak
Postal code
Approval date
2012-09-30, 1391/07/09
Ethics committee reference number
91-132-8

Health conditions studied

1

Description of health condition studied
Tuberculosis
ICD-10 code
A15.0
ICD-10 code description
Tuberculosis of lung, confirmed by sputum microscopy with or without culture

Primary outcomes

1

Description
Improved paraclinical tests
Timepoint
days of 14 , 28 , 42 , 56
Method of measurement
check of CRP

2

Description
Improved paraclinical tests
Timepoint
days of 14 , 28 , 42 , 56
Method of measurement
check of ESR

3

Description
Improved paraclinical tests
Timepoint
days of 14 , 28 , 42 , 56
Method of measurement
check of CBC

Secondary outcomes

1

Description
Improve of life quality
Timepoint
0 and 56
Method of measurement
standard questionairof GHQ-28

2

Description
accelerating weight gain
Timepoint
0 AND56
Method of measurement
Weight measurement

Intervention groups

1

Description
In case group Standard anti-tuberculosis treatment for 6 months plus l- arginine, 2 g daily in first month
Category
Treatment - Drugs

2

Description
In control group 6-month Anti-TB treatment plus placebo 2gram daily in first month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in central province
Full name of responsible person
Aliasghar Farazi
Street address
Department of Infectious diseases,Vali asr hospital, Arak ,Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpoo
Street address
Management of Research services,Sardasht, Arak University of Medical Sciences
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
Ghazaleh Akbarifard
Position
Secretary of research Council
Other areas of specialty/work
Street address
Sardasht,Arak,Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
gakbarifard@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliasghar Farazi
Position
Infectious Diseases Specialist
Other areas of specialty/work
Street address
Department of infectious diseases , Vali asr hospital,Arak
City
Arak
Postal code
Phone
+98 86 1223 6855
Fax
Email
farazialiasghar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical SCiences
Full name of responsible person
Aliasghar Farazi
Position
Infectious Diseases Specialist
Other areas of specialty/work
Street address
Department of Infectoius Diseases , Vali asr hospital , Arak
City
Arak
Postal code
Phone
00
Fax
Email
farazialiasghar@yahoo.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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