Assessing the effects of pomegranate juice consumption on clinical signs, matrix metalloproteinase 13 & glutathione peroxidase in patients with osteoarthritis of the knee.
Assessing the effects of pomegranate juice consumption on clinical signs, matrix metalloproteinase 13 & glutathione peroxidase in patients with osteoarthritis of the knee.
Objectives: The aim of this study is Effects of pomegranate juice consumption on clinical signs, matrix metalloproteinase 13 & glutathione peroxidase in patients with osteoarthritis of the knee. Design: Thirty eight patients with knee osteoarthritis participate in this study. The patients randomly divide into two groups of pomegranate juice and control. Pomegranate juice group consume 200 ml pomegranate juice daily for 6 weeks. No intervention do on the control group. Inclusion criteria: age: 30-80 yrs; diagnosis of osteoarthritis of the knee by a rheumatologist according to ACR criteria ( based on pain history, physical examination, laboratory and radiological findings); Willingness and ability to drink pomegranate juice and no allergy to this. Exclusion criteria: patients with inflammatory diseases; rheumatoid arthritis; diabetes mellitus; cardiovascular diseases; liver diseases; renal diseases; cancer; who treated with oral corticosteroids in the last 4 weeks; who injected corticosteroids in the last 6 months; antioxidants consumption and pregnancy. Main outcome variables: patients clinical signs included pain, stiffness and physical function ask from patiens at baseline and after intervention according to WOMAC questionnaire. Anthropometric assessment and nutritional status of patients will evaluate. Matrix metalloproteinase 13 & glutathione peroxidase in patients evaluate in two times.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014031517017N1
Registration date:2014-11-21, 1393/08/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-21, 1393/08/30
Registrant information
Name
Nasrin Ghoochani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
ghoochani.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effects of pomegranate juice consumption on clinical signs, matrix metalloproteinase 13 & glutathione peroxidase in patients with osteoarthritis of the knee.
Public title
Effects of pomegranate juice on osteoarthritis of the knee
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age:30-80 yrs; diagnosis of osteoarthritis of the knee by a rheumatologist according to ACR criteria ( based on pain history, physical examination, laboratory and radiological findings); ability to drink pomegranate juice and no allergy to this.
Exclusion criteria: patients with inflammatory diseases; rheumatoid arthritis; diabetes mellitus; cardiovascular diseases; liver diseases; renal diseases; cancer; who treated with oral corticosteroids in the last 4 weeks; who injected corticosteroids in the last 6 months; antioxidants consumption and pregnancy.
Age
From 30 years old to 80 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
Parallel
Other design features
Randomization between the two groups do by Block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
15794-61357
Approval date
2013-12-28, 1392/10/07
Ethics committee reference number
ajums.REC.1392.211
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
pain
Timepoint
before and after the intervention
Method of measurement
WOMAC questionnair
2
Description
stiffness
Timepoint
before and after the intervention
Method of measurement
WOMAC questionnair
3
Description
physical function
Timepoint
before and after the intervention
Method of measurement
WOMAC questionnair
Secondary outcomes
1
Description
sreum mmp13
Timepoint
before and after the intervention
Method of measurement
before and after the intervention
2
Description
serum glutathione peroxidase
Timepoint
before and after the intervention
Method of measurement
before and after the intervention
Intervention groups
1
Description
Intervention group: Daily consumption of 200 ml pomegranate juice produced by Takdaneh company for 6 weeks in intervention group
Category
Treatment - Other
2
Description
Control group: No intervention will do in control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan hospital, clinic of reumatology
Full name of responsible person
Dr Karim mowla
Street address
Golestan university hospital, Farvardin streat, Golestan, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
dr Nader Saki
Street address
Ahvaz, Ahvaz Jundishapur University of Medical Sciences-Vice Chancellor for Research and Technology
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Ahvaz Jundishapur 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
Nutrition & Metabolic Diseases Research Center , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasrin Ghoochani
Position
MSc student of nutrition science
Other areas of specialty/work
Street address
Nutrition & Metabolic Diseases Research Center , Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3373 8253
Fax
Email
n_ghoochani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition & Metabolic Diseases Research Center , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Majid Karandish
Position
PHD of nutrition science
Other areas of specialty/work
Street address
Nutrition & Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3373 8253
Fax
Email
mkarandish@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasrin Ghoochani
Position
MSc student of nutrition science
Other areas of specialty/work
Street address
Department of nutrition, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
61357-15794
Phone
00
Fax
Email
n_ghoochani@yahoo.com; ghoochani.n@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)