This study is a randomized double-blind placebo controlled trial that will carry on 60 diabetic patients according to specialist diagnosis from clinics of Tabriz University of Medical Science. The aim of the study is to evaluate the effect of zingiber officinal supplementation on some blood biochemical parameters in type 2 Diabetes Mellitus patients. Patients will be divided randomly to 2 groups; intervention group : patients recieve2 pill containing 1g powder of ginger herb, and placebo group patients take 2 pill containing 1g isomaltl for 60 days. Anthropometric measurements (weight, height), biochemical criteria including lipid profile (TG,TC,HDL-C,LDL-C), blood glucose, HbA1c and insulin using 5cc blood collected, physical activity levels and dietary record will be measured before and after treatment (8 week).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202232017N7
Registration date:2012-04-17, 1391/01/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-17, 1391/01/29
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger (zingiber officinale) on glucose, HbA1c and insulin sensitivity in type 2 diabetic patients
Public title
The effect of ginger (zingiber officinale) on glucose, HbA1c and insulin sensitivity in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years; proven diagnosis for diabetes mellitus by experts; absence of antioxidants supplementation in previous months or in the study and absence of special diet. Exclusion criteria: history of impaired immune system; alcohol use and depression,nephrotic syndrome, peptic ulcer, gastrointestinal disorders,Pregnancy and Lactation,Consumption of alcoholic beverages,food allergies.
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:
60
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz, East Azarbayjan ,Iran
City
Tabriz
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
9090
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Glucose and HbA1c
Timepoint
Before and after intervention
Method of measurement
Enzymatic method and ELISA method for HbA1c
Secondary outcomes
1
Description
Insulin sensitivity
Timepoint
Before and after intervention
Method of measurement
Insulin measured by ELISA
2
Description
Lipid profile
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method for total cholesterol and HDL and Freidwald’s formula for LDL
Intervention groups
1
Description
Intervention group:2 pill containing 1g powder of ginger for 60 day
Category
Treatment - Drugs
2
Description
Placebo group: 2 pill containing 1g powder of isomalt for 60 day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The clinics of Tabriz University Of Medical Sciences
Full name of responsible person
sepide mahluji
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz , East Azarbayjan ,Iran, Islamic Republic Of east azarbayjan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research-Tabriz University of Medical Science
Full name of responsible person
Mohammad Reza Rashidi
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz , East Azarbayjan ,Iran
City
Tabriz
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-Tabriz University of Medical Science
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
Tabriz University Of Medical Sciences
Full name of responsible person
Sepide Mahluji
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz East Azarbayjan Iran,
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
s_mahluji@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Associate professor in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz ,East Azarbayjan, Iran
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Sepide Mahluji
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz , East Azarbayjan ,Iran
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
s_mahluji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)