For several years garlic has been used for herbal in treatment of several disease. However, its efficacy in the treatment of this disease has not demonstrate yet.In this double blind study we investigate the effect of 12 weeks supplementation with garlic on body composition and severity of pain in patients with knee osteoarthritis. We investigated on 80 postmenopausal women with knee osteoarthritis. Subjects were randomly divided into two groups, they will take 500 mg garlic tablet or its placebo twice a day for 3 months. In every month, weight, height,waist and hip circumferences will measure.Before and after 12 weeks of intervention % fat and fat free mass with BIA will measure. In addition, pain and other symptoms will be assessed monthly by WOMAC questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307179543N2
Registration date:2013-09-11, 1392/06/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-11, 1392/06/20
Registrant information
Name
Sahar Dehghani
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7719 5576
Email address
sa-dehghani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences
Expected recruitment start date
2012-05-30, 1391/03/10
Expected recruitment end date
2012-06-30, 1391/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of garlic supplementation on body composition and knee pain in postmenopausal overweight and obese women with knee osteoarthritis
Public title
The effect of garlic on knee joint pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias: female, 50-75 years old,25 ≤ BMI ≤ 35, mild or moderate osteoarthritis. Exclusion criteria:severe pain or hip involvement; candidate for surgery; had a knee sergery; sensitivity of garlic; smoking; history of cardiovascular disease; type 1 diabetes; liver disease; hypo or hyper thyroid; kidney disease; arthritis; gout; cancer; any injection in knee in 3 month before intervention; intake of NSAIDs; HRT; astatine; warfarin and supplement like omega 3 or 6 and condroitin sulphate; being in a diet or weight loss about 5% during 3 month in this study.
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Central Organization Of Tehran University Of Medical Sciences
Street address
Central Organization Of Tehran University Of Medical Sciences, keshavarz ave, ghods ave
City
Tehran
Postal code
Approval date
2012-05-08, 1391/02/19
Ethics committee reference number
130/2783/د/90
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis ( arthritis of knee)
Primary outcomes
1
Description
Pain of knee based on "WOMAC" questionnaire
Timepoint
3 months
Method of measurement
"WOMAC" questionnaire
Secondary outcomes
1
Description
body composition
Timepoint
3 months
Method of measurement
bioelectrical impedance analysis
2
Description
Added at 2017-07-15: WOMAC physical function subscale score
Timepoint
Added at 2017-07-15: 12 weeks
Method of measurement
Added at 2017-07-15: questionnaire
Intervention groups
1
Description
1)drug: 500mg garlic tablet twice a day2)
Category
Treatment - Drugs
2
Description
placebo: 500 mg lactose twice a day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Ahmad Salimzadeh
Street address
30 Tir street, Emam khomeini street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Uuniversity Of Medical Science
Full name of responsible person
Dr.Mohammad Javad Hosseini Atar
Street address
Ghods ave, Keshavarz ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Uuniversity Of Medical Science
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
Tehran University Of Medical Science
Full name of responsible person
Sahar Dehghani
Position
student in Master of Science
Other areas of specialty/work
Street address
Tehran University of Medical Science, Keshavarz ave
City
Tehran
Postal code
Phone
+98 21 7719 5576
Fax
Email
sani_nut@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Dr. Mohammad javad Hosseinzadeh Atar
Position
PHD in Nutrition
Other areas of specialty/work
Street address
Ghods ave, Keshavarz ave
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
Email
Hosseinzadeh.MDphd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Sahar Dehghani
Position
Tehran University Of Medical Science
Other areas of specialty/work
Street address
Ghods ave, Keshavarz ave
City
Tehran
Postal code
Phone
00
Fax
Email
sani_nut@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)