This study investigated the effects of cinnamon in reducing HbA1c and BMI in patients with type II diabetes who ranged in age from 18 to 65 years, over the past six months did not change the dose or type of medication, have HbA1c less than 8 and blood pressure control (less than 140 / 90). 70 patients referred to clinic of Endocrinology and Metabolism of Imam Reza Hospital will be studied in two groups of 35 taking cinnamon capsules over a period of three months as a randomized double-blind placebo-controlled study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010713612N4
Registration date:2015-01-25, 1393/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Farzad Najafipour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
najafipourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Bone disease health center, Tabriz University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Cinnamon_Plus tablets on HbA1C in diabetic patients
Public title
Evaluating the effect of Cinnamon on HbA1C in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetes mellitus; Patients aged from 18 to 65 years old; HbA1c less than 8, blood pressure less than 140/90.
Exclusion criteria: diabetes type 1; Patients younger than 18 or older than 65 years; Having kidney, thyroid or liver disease simultaneously; HbA1c greater than 8; blood pressure over 140/90; Changing the dose or type of medication over the last six months; Pregnancy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93144
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Hemoglobin A1c
Timepoint
At baseline and three months after satrting treatment
Method of measurement
Chromatography
2
Description
Body Mass Index
Timepoint
At baseline and three months after starting treatment
Method of measurement
weight(kg)÷height(m)^2
Secondary outcomes
empty
Intervention groups
1
Description
In the first group Cinnamon Plus capsule will be used once daily for three months.
Category
Treatment - Drugs
2
Description
In the second group Placebo in form of a capsule will be used once daily for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Imam Reza Hospital
Full name of responsible person
Dr. Farzad Najafipour
Street address
Imam Reza medical research and training hospital, Daneshgah Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bone Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Amir Bahrami
Street address
Srourbakhsh Alley, Abresan, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bone Research Center, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Najafipour
Position
Assistant Professor of Endocrinology and Metabolic Diseases
Other areas of specialty/work
Street address
Srourbakhsh Alley, Abresan, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 4531
Fax
Email
najafipourf@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Najafipour
Position
Assistant Professor of Endocrinology and Metabolic Diseases
Other areas of specialty/work
Street address
Srourbakhsh Alley, Abresan, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 4531
Fax
Email
najafipourf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz medical university
Full name of responsible person
Dr.Javad Jafarpour
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz Department Of Internal Medicine
City
Tabriz
Postal code
Phone
00
Fax
Email
javadjafarpuor1355@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)