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The effect of Ginger consumption on the some immunity and inflammatory mediators in adult with active Rheumatoid arthritis referingto Shariaty Hospital

Protocol summary

Summary
This study examined the effect of Ginger on some inflammatory and Immunity factors in patients with active RA referring to shariaty Hospital. In a randomized, double-blind, placebo -controlled clinical trial, 70 patients ,age between 18-69 years old with Active RA after Rheumatologist examination and filling personal, medical and food questionnaires will be enrolled in the study. They will be divided in 2 groups (35 numbers in each group) including: 1- Ginger (case) 2-Placebo (control) randomly. Patients in case group will receive 1500 mg of powdered Ginger daily (by two 750 mg capsules) for 3 months and control patients will receive 1500 mg Wheat flour daily (by two 750mg capsules) , one 750 mg capsule before lunch and one before dinner for 3 months. Placebo capsules are completely similar to cases one and will divide randomly between Patients. Patients will be control weekly by calling and in the end of each month by visiting. before and After the 3 months intervention period this test for comparing two groups will be done: DAS28, ESR, CRP, ILIβ, TNFα, IL17, IL2, IL4, IL10 in two groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207109472N4
Registration date: 2014-03-19, 1392/12/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-19, 1392/12/28
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences IRAN University of Medical Sciences
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginger consumption on the some immunity and inflammatory mediators in adult with active Rheumatoid arthritis referingto Shariaty Hospital
Public title
The effect of Ginger powder consumption on inflammation and Immunity in Rheumatoid arthritis disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: person with RA diseases as ACR criteria, having RA from 2 years ago; age between 18-69 years; not being pregnant or lactated; not smoking and drink alcohol; haven’t eaten multivitamin or antioxidants supplements from 3 month ago; don't eat lowering blood pressure; don't eat anti pregnancy drugs, exclusion criteria: Changes in diet or physical activity every day; taking less than 80% of supplements given to patients at baseline(the compliance lower than %80); consumption of contraceptives, multivitamins and antioxidant supplements; renal , hepatic , thyroid, parathyroid diseases, cancer, heart diseases
Age
From 18 years old to 69 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 35
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
Tehran university of medical sciences
Street address
Tehran university of medical sciences,Research deputy
City
Tehran
Postal code
Approval date
2014-02-04, 1392/11/15
Ethics committee reference number
92-034122604-107079

Health conditions studied

1

Description of health condition studied
adult active Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified

Primary outcomes

1

Description
hsCRP
Timepoint
Before and after intervention
Method of measurement
Elisa

2

Description
IL17
Timepoint
Before and after intervention
Method of measurement
ELISA

3

Description
TNFa
Timepoint
Before and after intervention
Method of measurement
ELISA

4

Description
IL10
Timepoint
Before and after treatment
Method of measurement
ELISA

5

Description
IL2
Timepoint
Before and after intervention
Method of measurement
ELISA

6

Description
DAS28
Timepoint
Before and after study
Method of measurement
using ESR,CRP and number of joints with inflammation.

7

Description
IL4
Timepoint
Before and after treatment
Method of measurement
ELISA

8

Description
ESR
Timepoint
Before and after the study
Method of measurement
Westergern method

Secondary outcomes

1

Description
BMI
Timepoint
Before and after intervention
Method of measurement
weight(kg)/height(m*2)

2

Description
Nsaids intake
Timepoint
Before and after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention Group: Patients that refer to hospital shariatti have interval criteria and will receive Ginger voluntarily. Patients in case group will receive 1500 mg of powdered Ginger daily (by two 750 mg capsules) for 3 months ne 750 mg capsule before lunch and one before dinner for 3 months.
Category
Treatment - Other

2

Description
Control groups: Patients that refer to hospital shariatti have interval criteria and will receive starch or flour voluntarily. Patients in Control group will receive 1500 mg of wheat flour daily (by two 750 mg capsules) one 750 mg capsule before lunch and one before dinner for 3 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rhumatology research centre
Full name of responsible person
Farhad Shahram
Street address
Shariaty Hospital, Aleahmad street.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Tehran University of Medical Sciences, Vice chancellor for Research, I
Full name of responsible person
Mr Dr Masood Yonesian,Mr Dr Motevalian
Street address
Tehran University of Medical Sciences, Qods street, Keshavarz Bld
City
Tehran
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, Tehran University of Medical Sciences, Vice chancellor for Research, I
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 faculty, Iran University of Medical Sciences
Full name of responsible person
Naheed Aryaeian
Position
assistant Professor/PhD in Nutrition
Other areas of specialty/work
Street address
School of public health, Iran University of Medical Sciences, Hammat Bld.
City
Tehran
Postal code
Phone
+98 21 8670 4755
Fax
+98 21 8862 2706
Email
aryaeian@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naheed Aryaeian
Position
assistant professor/PhD.
Other areas of specialty/work
Street address
Department of nutrition, School of public of health, Iran University of Medical Sciences
City
Tehran
Postal code
1449614535
Phone
+98 21 8670 4755
Fax
+98 21 8862 2706
Email
n-aryaeian@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naheed Aryaeian
Position
assistant Professor/PhD.
Other areas of specialty/work
Street address
Nutrition department, School of public health, Iran University of Medical Sciences
City
Tehran
Postal code
Iran
Phone
+98 21 8670 4755
Fax
+98 21 8862 2707
Email
n-aryaeian@tums.ac.ir
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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