The objective of this study was the effect of ginger on pain and some pro-inflammatory cytokins in knee osteoarthritis patients. 100 patients with moderate pain were participated. Patients were randomly divided into two groups, ginger and placebo. Both of them took the capsules 500 mg (ginger as drug, starch as placebo). Duration of this intervention was 3 months. Pain was determined by using visual analog scale (VAS) and pro-inflammatory factors obtained at first and after 12 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112078321N1
Registration date:2012-05-24, 1391/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-24, 1391/03/04
Registrant information
Name
Zahra Naderi
Name of organization / entity
Yazd university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 938 869 2472
Email address
zhr_naderi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd university of medical sciences
Expected recruitment start date
2011-07-06, 1390/04/15
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger supplementation on pain and some pro-inflammatory cytokins in knee osteoarthritis patients
Public title
The effect of ginger supplementation on pain and inflammatory factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: to complete the inform consent; the presence of medium knee pain between 40mm and 70 mm on a 100-mm visual analog scale (VAS) during the preceding 24 hours; the age between 50 and 70 years; absence of following conditions: inflammatory disease, metabolic disorder such as diabetes, dementia, rheumatoid arthritis, fibromyalgia, gout, cancer or other serious disease, signs or history of liver or kidney failure, asthma requiring treatment with steroids; treatment with oral corticosteroids within the prior 4 weeks; intraarticular knee depo-corticosteroids within the previous 3 months; prior treatment with immunosuppressive drugs such as penicillamine; arthroscopy of the target joint within the previous yea; significant injury to the target joint within the previous 6 months; fever >38 degree C at screening; allergy to ginger. Exclusion criteria: serious complications; consumption of vitamin-mineral supplements or other nutritional supplements; consumption of analgesics.
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:
100
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
Yazd university of medical sciences
Street address
Bafgh road
City
Yazd
Postal code
Approval date
2011-08-07, 1390/05/16
Ethics committee reference number
57205
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthrosis
Primary outcomes
1
Description
pain
Timepoint
before the intervention and 12 weeks after the end of treatment
Method of measurement
visual analoge scale
Secondary outcomes
1
Description
some pro-inflammatory cytokins
Timepoint
before the intervention and after 12 weeks
Method of measurement
ELISA kit
Intervention groups
1
Description
Ginger group took the capsules 500 mg (ginger powder as drug) 2 times a day. Duration of this intervention was 3 months.
Category
Treatment - Drugs
2
Description
Placebo group took the capsules 500 mg (starch powder) 2 times a day. Duration of this intervention was 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam polyclinic of Yazd
Full name of responsible person
Dr. Ali Dehghan
Street address
Khatam polyclinic
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Scieces
Full name of responsible person
Dr. Hassan Mozaffari-Khosravi
Street address
Yazd university of medical sciences, Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Scieces
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 Sadooghi university of medical sciences
Full name of responsible person
Zahra Naderi
Position
Ms.c. student in nutrition
Other areas of specialty/work
Street address
Bafgh road, Shahid Sadooghi university of medical sciences
City
Yazd
Postal code
Phone
+98 35 1836 7668
Fax
Email
zhr_naderi@yahoo.com ; zhr_naderi@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd university of medical sciences
Full name of responsible person
Dr. Hassan Mozaffari-Khosravi
Position
PhD in nutrition
Other areas of specialty/work
Street address
Vice chancellor for research, Bahonar square
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd university of medical sciences
Full name of responsible person
Zahra Naderi
Position
MS.c. student in nutrition
Other areas of specialty/work
Street address
Bafgh road, Yazd university of medical sciences
City
Yazd
Postal code
Phone
+98 35 1836 7668
Fax
Email
zhr_naderi@yahoo.com ; zhr_naderi@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)