Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000703202
Ethics application status
Approved
Date submitted
9/12/2008
Date registered
14/08/2009
Date last updated
14/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double blind, placebo-controlled, parallel group, clinical trial to assess the treatment effects of garlic tablet administered for two weeks orally in subjects with pulmonary tuberculosis.
Scientific title
A randomised, double blind, placebo-controlled, parallel group, clinical trial to assess the treatment effects of garlic tablet administered for two weeks orally in subjects with pulmonary tuberculosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary tuberculosis 4106 0
Condition category
Condition code
Infection 4300 4300 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 treatment arms:

Randomised allocation to Garcin (1000mg).
Dosage - 2 tablets per day will be administered orally for the first 2 weeks of the standard antituberculosis regimen.
Intervention code [1] 3818 0
Treatment: Drugs
Comparator / control treatment
Placebo-lactose pills, but since it lacks the smell of the real drug, the treatment tablets are put in the vicinity of the plastic bags for a week and then the bags would be filled by palcebo. Dosage - 2 tablets per day will be administered orally for the first 2 weeks of the standard antituberculosis regimen.
Control group
Placebo

Outcomes
Primary outcome [1] 5192 0
sputum smear-negative pulmonary tuberculosis
Timepoint [1] 5192 0
At Baseline, 4, 8 weeks
Secondary outcome [1] 8743 0
Liver Function Tests 'Serum Glutamic Pyruvic Transaminase (SGPT), Serum Glutamic-Oxaloacetic Transaminase (SGOT)' 3X the baseline values plus clinical symptoms, or SGOT, SGPT 5X the baseline values would be considered antituberculosis induced hepatitis.
Timepoint [1] 8743 0
At Baseline , 2, 4, 8 weeks

Eligibility
Key inclusion criteria
Patients newly diagnosed with smear positive pulmonary tuberculosis admitted to the hospital who receive standard treatment
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Human Immune Deficiency Virus (HIV) positives, confirmed hepatitis at baseline, patients with cirrhosis, renal failure, and known hypersensitivity to garlic, those prone to hemorrhage, and hypotension

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The treatment allocation was randomised by a researcher who is not directly involved in the trial. Central randomization by telephone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1463 0
Iran, Islamic Republic Of
State/province [1] 1463 0

Funding & Sponsors
Funding source category [1] 4268 0
Hospital
Name [1] 4268 0
Masih Daneshvari Hospital, National Research Institute of Tuberculosis and Lung Diseases (NRITLD)
Country [1] 4268 0
Iran, Islamic Republic Of
Funding source category [2] 237482 0
Hospital
Name [2] 237482 0
Masih Daneshvari Hospital, National Research Institute of Tuberculosis and Lung Diseases (NRITLD)
Country [2] 237482 0
Iran, Islamic Republic Of
Primary sponsor type
Hospital
Name
Masih Daneshvari Hospital, National Research Institute of Tuberculosis and Lung Diseases (NRITLD)
Address
Masih Daneshvari Hospital, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Darabad, Tehran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3840 0
None
Name [1] 3840 0
Address [1] 3840 0
Country [1] 3840 0
Secondary sponsor category [2] 236966 0
None
Name [2] 236966 0
Address [2] 236966 0
Country [2] 236966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6320 0
Masih Daneshvari Research Ethics Committee
Ethics committee address [1] 6320 0
Masih Daneshvari Hospital, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Darabad, Tehran
Ethics committee country [1] 6320 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6320 0
Approval date [1] 6320 0
03/11/2008
Ethics approval number [1] 6320 0

Summary
Brief summary
We could not find any study that has examined the use of Garlic (Allium sativum, garlick) to treat tuberculosis as add on to antituberculosis regimen or to prevent drug induced hepatitis. It has been reported byGholami et al (pharmacy practice, 2006, 4(3): 134) that Antituberculosis -induced Hepatotoxicity in our region is much higher than western countries (25.9% vs 4.5%) . The proposed study will provide scientifically valid data to date on whether garlic is effective in preventing hepatitis induced by anti tuberculosis regimen or not..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35025 0
Address 35025 0
Country 35025 0
Phone 35025 0
Fax 35025 0
Email 35025 0
Contact person for public queries
Name 12372 0
Fanak Fahimi, Payam Tabarsi
Address 12372 0
Masih Daneshvari Hospital, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Darabad, Tehran.
Country 12372 0
Iran, Islamic Republic Of
Phone 12372 0
+98 921940902
Fax 12372 0
Email 12372 0
[email protected], [email protected]
Contact person for scientific queries
Name 3300 0
Professor Mohammad Reza Masjedi
Address 3300 0
Masih Daneshvari Hospital, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Darabad, Tehran.
Country 3300 0
Iran, Islamic Republic Of
Phone 3300 0
+98 21 20109991
Fax 3300 0
Email 3300 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.