The effect of Ginger supplementation consumption on some genes expression that are mediators of immunity and inflammation in adult with active Rheumatoid Arthritis
This study will examine the effect of Ginger on some inflammatory and Immunity Gene expression 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: The amout of Jene expression of NFkB، PPARγ، Foxp3، GATA3، T-bet, RORγ.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403109472N6
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
IRAN University of Medical Sciences
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginger supplementation consumption on some genes expression that are mediators of immunity and inflammation in adult with active Rheumatoid Arthritis
Public title
The effect of Ginger powder consumption on some genes expression that are mediators of immunity and inflammation in adult with Rheumatoid Arthritis
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
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Vice-chancellor for Research, Iran University of Medical Sciences
Street address
Hemmat Broadway
City
Tehran
Postal code
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
92-03-27-23598-100203
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
NFkB Jene expression amount
Timepoint
Before and after study
Method of measurement
PCR
2
Description
PPARγ Jene expression amount
Timepoint
Before and after study
Method of measurement
PCR
3
Description
Foxp3 Jene expression amount
Timepoint
Before and after study
Method of measurement
PCR
4
Description
GATA3 Jene expression amount
Timepoint
Before and after study
Method of measurement
PCR
5
Description
T-bet Jene expression amount
Timepoint
Before and after study
Method of measurement
PCR
6
Description
RORγ Jene expression amount
Timepoint
Before and after the study
Method of measurement
PCR
Secondary outcomes
1
Description
BMI
Timepoint
Before and after study
Method of measurement
Formula
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 - Drugs
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, Jalal Aleahmad Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr seid Ali Javad Mosavi
Street address
Vice-chancellor for Research, Iran University of Medical Sciences, Hammat Broadway
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, Iran 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
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
Nutrition faculty, School of public health, Iran University of Medical Sciences, Hammat Broad way