The purpose of this study is determining the impact of nutritional style of traditional medicine on HbA1c of type 2 diabetic patients referred to Yazd Diabetes Centre.
Type of this study is Randomized Controlled Clinical Trial(RCCT).
Inclusion criteria: definite diagnosis of diabetes mellitus that affirmed with Fbs>126 in twice & the specialist confirmed it; their hba1c will be between 7.5 t0 9.5;
they want and could cooperate in study ;
they should not have pregnancy or lactation ,malignancy and Alzheimer ;
they should not have any complication of Diabetes mellitus, like cardiovascular or renal disorders.
Exclusion criteria:
patient un cooperate within study ; wont come at determined time ;because of increasing level of blood glucose need to intervention ;unpredictable problem that interact with study
sample volume is 26 persons in each group.
initial HbA1c of all patients will be evaluated and recorded at first . the nutritional style of traditional medicine will be taught to The intervention group. HbA1c of both groups should be evaluated and recorded after 3 months of follow up, then results will be compared with the first
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080129150N1
Registration date:2016-08-15, 1395/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-15, 1395/05/25
Registrant information
Name
Seyedkazem Kazemeini
Name of organization / entity
Yazd Shahid sadooghi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 353740171
Email address
sk.kazemeini@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Funding was provided By Yazd Shahid sadooghi University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of nutritional management in view of Iranian traditional medicine on HbA1c in type 2 diabetics referred to yazd diabete centre
Public title
Effect of traditional medicine nutritional style on diabetes mellitus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: definite diagnosis of diabetes mellitus that affirmed with FBS>126 in twice & the specialist confirmed it; their hba1c will be between 7.5 t0 9.5; they want and could cooperate in study ; they should not have pregnancy or lactation ,malignancy and Alzheimer ; they should not have any complication of Diabetes mellitus, like cardiovascular or renal disorders.
Exclusion criteria:
patient un cooperate within study ; wont come at determined time ;because of increasing level of blood glucose need to intervention ;unpredictable problem that interact with study
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Shahid Sadooghi Univesity of Medical Sciences
Street address
Bahonar Squre
City
Yazd
Postal code
Approval date
2015-11-30, 1394/09/09
Ethics committee reference number
IR.SSU.REC.1394.120
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E12
ICD-10 code description
Malnutrition-related diabetes mellitus
Primary outcomes
1
Description
HbA1c
Timepoint
3 month
Method of measurement
HbA1c lab test
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Patients in the intervention group feeding correct method based on traditional medicine are taught face to face and then checked before and after the three-month period
Category
Lifestyle
2
Description
In the control group of patients will be asked to continue with the previous method of feeding your doctor and Hba1c be examined at the beginning and end of the 3 month period
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabete Center
Full name of responsible person
Seyedkazem Kazemeini
Street address
Bahonar squre. Shahidsadooghi Ave
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahidsadooghi University of Medcal Sciences
Full name of responsible person
Amirhooshang Mehrparvar
Street address
Bahonar Squre
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahidsadooghi University of Medcal 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
Traditional Medicine Factulty of Ardakan
Full name of responsible person
Seysdkazem Kazemeini
Position
Student (ph.D candidate)
Other areas of specialty/work
Street address
Imam Ave
City
Ardakan
Postal code
Phone
+98 35 3223 8916
Fax
Email
sk_kazemeini@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Traditional Medicine Factulty of Ardakan
Full name of responsible person
Majid Emtiazi
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Ave. Traditional Medicine Factulty of Ardakan
City
Ardakan
Postal code
Phone
+98 35 3223 8916
Fax
Email
dr.emtiazy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional Medicine Factulty of Ardakan
Full name of responsible person
Seyedkazem Kazemeini
Position
Student (ph.D candidate)
Other areas of specialty/work
Street address
Traditional Medicine Factulty of Ardakan. Imam Ave
City
Ardakan
Postal code
Phone
+98 35 3223 8916
Fax
Email
sk_kazemeini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)