Protocol summary

Summary
This study is a double-blind clinical trial that will be carried out for 3 months on 80 postmenopausal obese women (75-50 years), with knee osteoarthritis who were referred to Sina Hospital Clinic. at first the disease in people with knee osteoarthritis is diagnosed by a rheumatologist and if there is no exclusion criteria include:severe pain or hip involvement; candidate for surgery; sensitivity of garlic; smoking; history of cardiovascular disease; type 1 diabetes; liver disease; hypo or hyper thyroid; arthritis,women will be include in this study. Women will be randomly divided into two groups: 40 patients in the intervention group received 500 mg garlic supplements, two times a day and another 40 women in the control group, will receive 500 mg placebo. Blood samples from each of the participants at the beginning and end of project will be compare( In order to evaluate and compare the inflammatory factors such as tumor necrosis factor-alpha and serum Resistin and fasting blood sugar). Patients monthly in terms of dietary intake of macronutrients and micronutrients (through questionnaires during 24 hours recall), physical activity (via questionnaires international Matt), weight, body composition (percent fat and fat free mass using the BIA) , height and BMI will be checked. all information will be saved in spss v.19.

General information

Acronym
_____
IRCT registration information
IRCT registration number: IRCT201204239543N1
Registration date: 2012-06-10, 1391/03/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-06-10, 1391/03/21
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
Effects of garlic supplementation on serum levels of resistin, tumor necrosis factor-α in post menopause overweight and obese women with knee osteoarthritis
Public title
Effect Of Garlic In Knee osteoarthrosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: women; 50-75 years old; postmenopausal; obese body mass index between 25 - 35 with moderate and severe knee osteoarthritis Diagnosis by rheumatologist. 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 University, 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 [arthrosis of knee]

Primary outcomes

1

Description
Resistin
Timepoint
Week 12
Method of measurement
Lab kit

2

Description
Tumor Necrosis Factor-Alpha
Timepoint
Week 12
Method of measurement
kit

Secondary outcomes

1

Description
Body Composition (Fat mass, Fat Free Mass)
Timepoint
Week 12
Method of measurement
Bio Electrical Impedance

2

Description
Fasting Blood Sugar
Timepoint
Week 12
Method of measurement
ELISA kit

3

Description
Weigth
Timepoint
Week 12
Method of measurement
Balance

Intervention groups

1

Description
Drug (Garlic tablet 500 Mg, Twice a day for 3 month)
Category
Treatment - Drugs

2

Description
Placebo twice a day for 3 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr.Ahmad Salimzadeh
Street address
Sina Hospital, Emam khomeyni Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr.Mohammad Javad Hosseinzadeh
Street address
Tehran University Of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University Of Medical Sciences
Full name of responsible person
Sahar Dehghani
Position
Student Of MSc
Other areas of specialty/work
Street address
Tehran University Of Medical Sciences
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 Sciences
Full name of responsible person
Dr.Mohammad javad Hosseinzadeh Atar
Position
PHD
Other areas of specialty/work
Street address
Tehran University Of Medical Sciences
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 Sciences
Full name of responsible person
Sahar Dehghani
Position
Student Of MSc
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
sani_nut@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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