This investigation is a randomized controlled clinical trial to determine the effect of ginger on hypertention in patients with type 2 diabetes The sample size of study is 84 cases.IInclusion criteria: patients with type 2 diabetes ,patients newly diagnosed diabetes to 10 years, no pregnancy and lactation, lack of vitamin and mineral supplementation, without any thyroid , kidney , CVD diseases and not using TG & cholesterol lowering drugs,and also using ESTROGEN or PROGESTRON, FBS<180, 2Hpp<250 . Exclusion criteria: using insulin They are randomly selected. They are assigned to two groups based on random numbers table. patients receive capsules ginger or placebo 3 times a day, 1 gram for 2 months. hypertention is measured .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111306278N2
Registration date:2012-02-16, 1390/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-16, 1390/11/27
Registrant information
Name
Behrouz Talaei
Name of organization / entity
Yazd University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
b.talaei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences and Health Services
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of ginger on hypertention in patients with type 2 diabetes
Public title
The effects of ginger on type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with type 2 diabetes ,patients newly diagnosed diabetes to 10 years, no pregnancy and lactation, lack of vitamin and mineral supplementation, without any thyroid , kidney , CVD diseases and not using TG & cholesterol lowering drugs,and also using ESTROGEN or PROGESTRON, FBS<180, 2Hpp<250 . Exclusion criteria: using insulin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
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
University of Medical Sciences and Health Services
Street address
University of Medical Sciences and Health Services-Bahonar sq-YAZD
City
YAZD
Postal code
Approval date
2011-11-23, 1390/09/02
Ethics committee reference number
پ/17/1/105713
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Diabetes
Primary outcomes
1
Description
Systol Hypertention
Timepoint
Before - every two weeks during the intervention and after intervention
Method of measurement
mmhg
2
Description
Diastole Hypertention
Timepoint
Before - every two weeks during the intervention and after intervention
Method of measurement
mmhg
3
Description
Mean Arterial Pressure
Timepoint
Before - every two weeks during the intervention and after intervention
Method of measurement
mmhg
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: capsules ginger 1 gr 3 times per day
Category
Treatment - Drugs
2
Description
Control: capsules 1 gr microcristalin cellulose, 3 times per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Behrouz Talaei Khales soflaei
Street address
Jomhuri blv- YAZD
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari
Street address
Bahonar sq.Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences and Health Services
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
University of Medical Sciences and Health Services
Full name of responsible person
Behrouz Talaei Khales soflaei
Position
MS student of Health Science in Nutrition
Other areas of specialty/work
Street address
University of Medical Sciences and Health Services
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
+98 35 1724 9333
Email
b.talaei@ssu.ac.ir b_talaei@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari
Position
PhD, nutritionist
Other areas of specialty/work
Street address
Bahonar sq, Yazd
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
+98 35 1724 9333
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences and Health Services
Full name of responsible person
Behrouz Talaei Khales Soflaei
Position
MS student of Health Science in Nutrition
Other areas of specialty/work
Street address
Daneshju blvd, Yazd University of Medical Sciences and Health Services ,Yazd
City
Yazd
Postal code
Phone
+98 35 1525 8234
Fax
+98 35 1522 3999
Email
b.talaei@ssu.ac.ir b_talaei@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)