The aim of this randomized double blind clinical trial study is examination the effect of garlic tablet on pro-inflammatory cytokines in post-menopause osteoporotic women. Subjects are post-menopause osteoporotic women in neck femur and lumbar spine aged 45-65 years who were randomly selected from Yazd Bone Mass Densiometery. Women with Heart disease, Hypertension or Hyperlipidemia that take Aspirin, Captopril, lipid lowering drug or women with peptic ulcer and sensitive to garlic are excluded from this study. Sample size is 22 cases in each group (intervention – placebo). Subjects in intervention group take two 570mg tablets of garlic per day for 1 month and those in placebo group take 2 placeboes per day for 1 month. Blood specimens are obtained before and after intervention and serum is separated and cytokines measure by ELISA kits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811183273N1
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Hamideh Hesabgar
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
mozaffari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadughi University of Medical Sciences and Health Services
Expected recruitment start date
2010-03-06, 1388/12/15
Expected recruitment end date
2010-04-04, 1389/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Garlic tablet on Pro-Inflammatory Cytokines in Post-menopause Osteoporotic Women
Public title
The effect of garlic tablet in prevention of osteoporosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: post-menopause osteoporotic women in lumbar spine or neck femur,
Exclusion criteria: Subjects with heart diseases & Hypertension that take Aspirin, Captopril or other Anti-coagolant drugs, hyperlipidemic patients that take lipid lowering drugs and people with Peptic Ulcer and hypersensitivity to Garlic
Age
From 45 years old to 65 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Shahid Sadughi University of Medical Sciences and Health Services
Street address
Second Centeral Building of Shahid Sadughi University of Medical Sciences and Health Services, Shahid Bahonar square, Yazd, Iran
City
Yazd
Postal code
Approval date
2010-03-10, 1388/12/19
Ethics committee reference number
پ/1/116334
Health conditions studied
1
Description of health condition studied
osteoporosis
ICD-10 code
M81.1
ICD-10 code description
Postmenopausal osteoporosis
Primary outcomes
1
Description
The rate of cytokines involved in osteoporosis
Timepoint
Before and after intervention
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Garlic, 2 tablets (570mg) per day for 1 month
Category
Treatment - Drugs
2
Description
Placebo 2 tablets (570mg) per day for 1 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Bone Mass Densiometery
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Full name of responsible person
Hassan Mozaffari
Street address
Second Centeral Building of Shahid Sadughi University of Medical Sciences and Health Services - Shahid Bahonar sq - Yazd - iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadughi University of Medical Sciences and Health Services
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
Shahid Sadughi University of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari
Position
PhD
Other areas of specialty/work
Street address
3rd floor, Centeral Building of Shahid Sadughi University of Medical Sciences and Health Services, Shahid Bahonar sq, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1724 9333
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Full name of responsible person
Dr Mohammad Bagher Owlia
Position
MD/ Rheumatologist
Other areas of specialty/work
Street address
Deputy of Education, Second floor, Saddoghi hospital, Atlasi Square, Safaie, Yazd
City
Yazd
Postal code
Phone
+98 35 1825 5550
Fax
Email
owlia@ssu.ac.ir
Web page address
http//: mbowlia.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Full name of responsible person
Hamideh Hesabgar
Position
MS student of Health Science in Nutrition
Other areas of specialty/work
Street address
Shahid Sadughi University of Medical Sciences and Health Services
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)