The purpose of this study was to investigate the effects of sesame on lowering serum lipids and enhancing antioxidant capacity and improving clinical signs in people with knee osteoarthritis. A total of 50 patients grade 1-3 osteoarthritis, aged 50 to 70 years old, were randomly assigned into intervention or control group. The patients in both groups received physiotherapy (20 1-hour sessions for both knees) as well as Acetaminophen 500mg twice a day and Glucosamine one tablet daily for two months. The patients in the intervention group received, as well, 40 grams of sesame powder daily for 2 months. The inflammatory markers including IL-6and hs-CRP as well as lipid profile, clinical signs and anti-oxidative status were measured before and after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011164105N4
Registration date:2011-01-15, 1389/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-15, 1389/10/25
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
faculty of health and nutrition-tabriz
Expected recruitment start date
2010-11-01, 1389/08/10
Expected recruitment end date
2010-11-20, 1389/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Sesame Seed on inflammatory markers and clinical sign in patient with knee osteoarthritis
Public title
Effect of Sesame Seed on inflammatory markers and clinical sign in patient with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 50-70years old, primary bilateral knee osteoarthritis based on ACR criteria, ability to consume and sesame
Exclusion criteria: grade IV osteoarthritis, secondary OA, active synovitis, knee surgery or intra-articular injection, neuromuscular diseases, diabetes, metabolic diseases, cardiovascular diseases, hepatic diseases, smoking, alcohol, vitamin, and mineral supplement consumption, MI
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences and Health Services
Street address
Attare Neyshaburi St, Tabriz
City
Tabriz
Postal code
Approval date
2010-11-08, 1389/08/17
Ethics committee reference number
8941
Health conditions studied
1
Description of health condition studied
knee OA
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Inflammatory markers (IL-6)
Timepoint
Before and after the intervention
Method of measurement
Elisa
2
Description
Markers of Lipidemia
Timepoint
Before and after the intervention
Method of measurement
Espectrophotometry(mg/dl)
3
Description
clinical sign
Timepoint
Before and after the intervention
Method of measurement
physical assessment
4
Description
Timed up and go test
Timepoint
Before and after the intervention
Method of measurement
based on walking time
5
Description
hs-CRP
Timepoint
Before and after the intervention
Method of measurement
Imonoturbidometry
6
Description
Koos questionnaire
Timepoint
before and after intervention
Method of measurement
Koos questionnaire
Secondary outcomes
1
Description
GPX
Timepoint
Before and after the intervention
Method of measurement
u/gr Hemoglubin- spectrophotometry
2
Description
SOD
Timepoint
Before and after the intervention
Method of measurement
spectrophotometry
3
Description
MDA
Timepoint
Before and after the intervention
Method of measurement
spectrophotometry
4
Description
Total Antioxidant
Timepoint
Before and after the intervention
Method of measurement
spectrophotometry
Intervention groups
1
Description
Sesame powder, 40 grams daily, for 2 months as well as physiotherapy (20 an-hour sessions for both knees), Acetaminophen 500mg twice a day, and Glucosamine one tablet daily for two months
Category
Treatment - Other
2
Description
Physiotherapy (20 an-hour sessions for both knees) as well as Acetaminophen 500mg twice a day and Glucosamine one tablet daily for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaa hospital
Full name of responsible person
Dr Eftekhar Sadat
Street address
Golshahr St.
City
Tabriz
2
Recruitment center
Name of recruitment center
Shahid Madani hospital
Full name of responsible person
Dr Eftekhar Sadat
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr Rasool Azarfarin
Street address
Daneshgah St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Beit Allah Alipour
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Health and Nutrition,Attare Neyshaburi St.
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
balipoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Beit Allah Alipour
Position
Other areas of specialty/work
Street address
Faculty of Health and Nutrition
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)