comparison of routine drug regime of blood glucose control with cinnamon and routine drug regime with placebo on FBS and Hb1AC in patients with non insulin dependent diabetes; A double blind randomized controlled clinical trial
The aim of this clinical trial is comparison of routine drug regime of blood glucose control with cinnamon and routine drug regime with placebo on FBS and Hb1AC in patients with non insulin dependent diabetes that 138 patients referred to diabetes clinic of Valiasr hospital Birjand who meet the inclusion criteria and willing to cooperate in the study selected by convince sampling and assigned in two experimental (69 people) and control groups (69 people) based on randomized blocking allocation. 5 ml of 8 hours of fasting, venous blood from all patients sent to the Central Laboratory University and fasting blood glucose and serum levels of hemoglobin A1C measured by biochemical and HBLC methods respectively. In order to control blood glucose, all patients receive the routine treatment of diabetes based on approved protocol treatments. Besides that, experimental group given three capsules of 500 mg Cinnamon per day before breakfast, lunch and dinner for 90 days. In control group, samples receive three vitamin C capsules as placebo daily that their shape, size and color were similar to the capsules of the intervention group. After the drug administration (90th day), the level of fasting blood glucose and serum levels of hemoglobin A1C measured in the same condition while patients and physicians responsible for collecting data informed about the treatment type.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100230098N1
Registration date:2016-10-30, 1395/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Azadeh Zahedifar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3244 5402
Email address
azadehzahedifarr@bum.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology affairs of Birjand University of Medical Sciences (BUMS)
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of routine drug regime of blood glucose control with cinnamon and routine drug regime with placebo on FBS and Hb1AC in patients with non insulin dependent diabetes; A double blind randomized controlled clinical trial
Public title
The effect of cinnamon on the level of FBS and Hb1AC in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type II non-insulin dependent diabetes, blood levels of hemoglobin A1C between 6.5 and 7.5, desire to participate in the study.
Exclusion criteria: not regular referring to diabetes control center, hemolytic anemia and thalassemia diseases, recent infusion of blood, uremia, allergy to cinnamon, kidney, liver and parathyroid diseases and intestinal problems, pregnancy, lactation, drug intolerance, signs of allergy to cinnamon, taking insulin, unexpected events and death
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
138
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
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari street
City
Birjand
Postal code
Approval date
2014-11-30, 1393/09/09
Ethics committee reference number
1393/09-08
Health conditions studied
1
Description of health condition studied
Non-insulin-dependent diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting glucose levels
Timepoint
Before intervention and 90 days after taking medication
Method of measurement
Blood sampling and determination of fasting glucose levels by enzymatic method
2
Description
Hemoglobin A1C
Timepoint
Before intervention and 90 days after taking medication
Method of measurement
Blood sampling and determination of the glycosylated hemoglobin by HPLC method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine treatment of diabetes to control blood sugar under approved therapy protocols, patients will receive three500 mg capsules of cinnamon daily before breakfast, lunch and dinner.
Category
Treatment - Drugs
2
Description
Control group: In addition to routine treatment of diabetes to control blood sugar under approved therapy protocols, samples will receive daily three vitamin C capsules as placebo that their shape, size and color are similar to the capsules of the intervention group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinic of Valiasr Hospital Birjand
Full name of responsible person
Vajehollah Raeesi
Street address
Valiasr hospital, Ghafari street, Birjand
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzadeh
Street address
Vice chancellor for research, Birjand University of Medical Sciences, Ghafari street
City
Birjand
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, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Azadeh zahedifar
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Valiasr hospital, Ghafari street, Birjand
City
Birjand
Postal code
Phone
+98 28 3322 4609
Fax
Email
azadehzahedifar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Khodashenas
Position
Resident of internal sciences
Other areas of specialty/work
Street address
Valiasr hospital, Ghafari street, Birjand
City
Birjand
Postal code
Phone
+98 56 3244 5402
Fax
Email
Krudsari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Azadeh zahedifar
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Valiasr hospital, Ghafari street
City
Birjand
Postal code
Phone
+98 56 3244 5402
Fax
Email
azadehzahedifar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)