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The effect of pomegranate extract on clinical index, inflammation markers and oxidative stress of Rheumatoid Arthritis patient in 1390

Protocol summary

Summary
The aim of this study is evaluate the effect of pomegranate supplement on complications in patients with Rheumatoid Arthritis, 50 Rheumatoid Arthritis patients ,aged 18-65 years old, were recruited from Shiraz Motahari Polyclinic and Ahvaz Aria hospital. The patients were randomly assigned into the two groups to receive 2 pomegranate supplements ,in the form of capsules, equal to 500 mg or placebo for 2 months. At baseline and at the end of the second month, the index of Disease activity score in 28 joints, Duration of morning stiffness, Health assessment questionnaire, Matrix metalloproteinase 3, ESR, CRP, Glutathione peroxidase and MDA and in order to controlling the confounding factors, weight, height, BMI, food frequency, disease duration, drugs type and dosage will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202183236N2
Registration date: 2012-03-07, 1390/12/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-07, 1390/12/17
Registrant information
Name
Zohreh Mazloom
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1008
Email address
zmazloom@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of pomegranate extract on clinical index, inflammation markers and oxidative stress of Rheumatoid Arthritis patient in 1390
Public title
Effect of pomegranate supplement on Rheumatoid Arthritis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Rheumatoid arthritis patients which their disease diagnosed according to the revised American Rheumatism Association criteria, ages between 18-65 years old, RA patients who don’t have enough clinical and laboratory response to conventional disease modifying anti rheumatic drugs (Methotrexate, Hydroxychloroquine, Sulphasalazine, and prednisolone), No drug type and dose fluctuation since 1 month prior to the study and during intervention period. Exclusion criteria: Presence of Chronic disease such as diabetes, cardiovascular, hepatic, kidney, gastrointestinal diseases, and severe infection, smoking, Alcohol consumption, use of supplements (antioxidants, multivitamins,...), patients with known allergy and food intolerance.
Age
From 18 years old to 65 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central Medical Building, Zand Avenue, PO Box 1978-71345
City
shiraz
Postal code
Approval date
2011-11-19, 1390/08/28
Ethics committee reference number
5811-90

Health conditions studied

1

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06
ICD-10 code description
Other rheumatoid arthritis

2

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive rheumatoid arthritis

Primary outcomes

1

Description
Disease activity
Timepoint
Before and 2 months after intervention
Method of measurement
DAS 28

2

Description
Disability and Pain scales
Timepoint
Before and 2 months after intervention
Method of measurement
health Assessment Questionnaire for Rheumatoid Arthritis patients

3

Description
Duration of morning stiffness
Timepoint
Before and 2 months after intervention
Method of measurement
Taking history and Questionnaire

Secondary outcomes

1

Description
Glutathione peroxidase
Timepoint
Before and 2 months after intervention
Method of measurement
ELIZA kit

2

Description
MDA
Timepoint
Before and 2 months after intervention
Method of measurement
Spectrophotometry

3

Description
CRP
Timepoint
Before and 2 months after intervention
Method of measurement
ELIZA kit

4

Description
ESR
Timepoint
Before and 2 months after intervention
Method of measurement
Westergren

5

Description
MMP3
Timepoint
Before and 2 months after intervention
Method of measurement
ELIZA kit

Intervention groups

1

Description
Placebo(2 capsules) intake per day, for 2 months
Category
Placebo

2

Description
Pomegranate supplement(2 capsules) intake is equivalent to 500 mg per day, for 2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic 2, Aria hospital
Full name of responsible person
Street address
East 17th street- Kianpars
City
Ahvaz

2

Recruitment center
Name of recruitment center
Shiraz Motahari polyclinic
Full name of responsible person
Street address
Motahari polyclinic - Namazi square-Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research OF Shiraz university of medical sciences
Full name of responsible person
Dr. Mohammad Ali Sahmedini
Street address
Central medical building, Zand avenue
City
Shiraz
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 OF Shiraz 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
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Person responsible for general inquiries

Contact
Name of organization / entity
School of health & nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Elham Tavakoli
Position
MSc student of nutrition
Other areas of specialty/work
Street address
Department of nutrition, School of health & nutrition,Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71172510018
Fax
Email
elham1tavakoli@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of health & nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Zohreh Mazloom
Position
PHD of nutrition, assistant professor of nutrition department, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Department of nutrition, School of health & nutrition, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71172510018
Fax
Email
zmazloom@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Tavakoli
Position
MSc student of nutrition
Other areas of specialty/work
Street address
School of health & nutrition, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71172510018
Fax
Email
elham1tavakoli@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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