This study examined The effect of Ginger on Clinical signs and blood pressure in patients with active RA. In this 21 months placebo-controlled double-blind randomized clinical trial, 70 patients with Active RA will be enrolled in the study.They will be devided in 2 groups randomly. Patients in case group will receive 1600 miligrams of powdered Ginger daily for 3 months and control patients will receive 1600 miligrams flour daily for 3 months (one 800 milligrams capsule before lunch and one before dinner). before and After the 3 months intervention period, Clinical signs(Pain, Morning stiffness,number inflammation joints and global physician assessment) and blood pressure in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206179472N3
Registration date:2012-09-29, 1391/07/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-29, 1391/07/08
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
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2013-06-01, 1392/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger consumption on the Clinical Manifestation and Blood Pressure in adult with Active Rheumatoid Arthritis
Public title
Effect of Ginger consumption on the Clinical Manifestation and Blood Pressure in adult with Rheumatoid Arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: person with RA diaseases as ACR criteria; having RA from 2 years ago; age between 20-69 years; not being pregnant or lactated; not smoking and drink alcoho; havn'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 compaliance lower than %80); consumption of contraceptives; multivitamins and antioxidant supplements; renal, hepatic,thyroid, parathyroid diseases, cancer and heart diseases.
Age
From 20 years old to 70 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
Etics commitee in Research of University
Street address
Tehran University of Medical Sciences, Research Deputy
City
Tehran
Postal code
Approval date
2012-08-14, 1391/05/24
Ethics committee reference number
91-01-27-17716-61438
2
Ethics committee
Name of ethics committee
Etics Commitee in Research of Tehran University of Medical Siences
Street address
Research Deputy, Trehran University of Medical Sciences,
City
Tehran
Postal code
Approval date
2012-11-04, 1391/08/14
Ethics committee reference number
91-01-27-17716-61438
Health conditions studied
1
Description of health condition studied
Adult with Active Rheumatoid Arthritis
ICD-10 code
M06.8
ICD-10 code description
Other specified Rheumatoid Arthritis
Primary outcomes
1
Description
Pain
Timepoint
Before and after intervention
Method of measurement
Visual analogue scales
2
Description
Number of inflammated joints
Timepoint
Before and after intervention
Method of measurement
Examintion
3
Description
Morning stiffness
Timepoint
Before and after intervention
Method of measurement
Examintion
4
Description
Global physician assesment
Timepoint
Before and after intervention
Method of measurement
Examintion
5
Description
Sistolic Blood pressure
Timepoint
Before and after intervention
Method of measurement
Sphygmomanometer
6
Description
Distolic Blood pressurs
Timepoint
Before and after intervention
Method of measurement
Sphygmomanometer
Secondary outcomes
1
Description
BMI
Timepoint
Before and after intervention
Method of measurement
weight/height^2
2
Description
Waist Circumference
Timepoint
Before and after study
Method of measurement
Tape
Intervention groups
1
Description
taking Ginger supplement, 1600 miligram (2* 800 milligrams capsules ginger powder per day. during 3 months (12 weeks)
Category
Treatment - Other
2
Description
taking Placebo, 1600 miligram (2* 800 milligrams capsules) Starch powder per day during 3 months (12 weeks).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Research Centre
Full name of responsible person
Professore Dr Farhad Shahram
Street address
Hospital Shariaty, Aleahmad street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Mrs Ahadi
Street address
Tehran University of Medical Sciences, Keshavarz Bld - intersection of Qods street
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
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
Tums(Tehran 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 and Biochemistry Department , School of Public Health, Tehran University of Medical Sciences, Poresina Street
City
Tehran
Postal code
Phone
+98 21 8877 7674
Fax
+98 88779487
Email
n-aryaeian@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
TUMS
Full name of responsible person
Naheed Aryaeian
Position
Assistant Professor/ PhD in Nutrition
Other areas of specialty/work
Street address
Nutrition and Biochemistry Department, School of public Health, Tehran University of Medical Sciences, Poresina Street
City
Tehran
Postal code
00982188779487
Phone
+98 21 8877 9487
Fax
Email
n-aryaeian@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naheed Aryaeian
Position
Assistant Professor
Other areas of specialty/work
Street address
Nutrition and Biochemistry Department, shcool of public Health,Poresina Street
City
Tehran
Postal code
Phone
+98 21 8877 7674
Fax
+98 21 8877 9487
Email
n-aryaeian@tums.ac.ir
Web page address
n-aryaeian@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)