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The effect of cinnamon on hemoglobin A1c in type 2 diabetic patients

Protocol summary

Study aim
Determining the effect of cinnamon on HbA1c in type 2 diabetic patients
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 1 on 126 patients, where computer random numbers were used for randomization by the supervisor.
Settings and conduct
In this trial, after obtaining the code of ethics, 126 patients of Farahikhetgan Hospital with type 2 diabetes were included in the study. The patients and the researcher were blinded in this study, and for this purpose randomization was done by the supervisor using computer random numbers. For the treatment group Two cinnamon capsules were prescribed daily for 12 weeks and for the control group, the same amount of placebo was prescribed for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30 to 70 years; Informed consent; patients of Farahehtegan Hospital; Type 2 diabetes. Exclusion criteria: patients with diabetes along with hypertension, ischemic heart diseases,, rheumatological diseases, renal diseases, insulin treatment, history of bleeding diseases, being treated with anticoagulants such as warfarin or NOAC.
Intervention groups
For the treatment group, two cinnamon capsules were prescribed daily for 12 weeks, and for the control group, placebo the same amount was prescribed for 12 weeks.
Main outcome variables
The effect of cinnamon supplementation for 12 weeks on reducing fasting blood sugar, hemoglobin A1c, triglycerides and cholesterol has been insignificant.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230611058448N1
Registration date: 2023-09-12, 1402/06/21
Registration timing: registered_while_recruiting

Last update: 2023-09-12, 1402/06/21
Update count: 0
Registration date
2023-09-12, 1402/06/21
Registrant information
Name
Zahra Sormeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7762 2366
Email address
alirezapanahian72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-03, 1402/06/12
Expected recruitment end date
2023-12-03, 1402/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cinnamon on hemoglobin A1c in type 2 diabetic patients
Public title
The effect of cinnamon on blood sugar in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 30 years and less than 70 years Informed consent suffering from type 2 diabetes Patients of Farahehtegan Hospital
Exclusion criteria:
Patients with hypertension Insulin treatment History of bleeding diseases Being treated with anticoagulants such as warfarin or NOAC Patients with kidney diseases Patients with ischemic heart disease Patients with rheumatological diseases
Age
From 30 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Since the study is double-blind, the randomization was done by the supervisor. Each patient was assigned a number from 1 to 126. Then, in order to divide people into two groups, control and treatment, online random number generation was used and 63 random numbers were generated from 1 to 126, based on these numbers, these people were placed in the treatment group and the remaining numbers were in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The doctor is unaware of the study groups, the patient is unaware of the study groups, the researcher is unaware of the study groups, the data analyst is unaware of the study groups .The division of patients into drug and placebo groups is done by nurses outside of the above groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, corner of Gol Yakh St., Ayane Blvd., Amir Pabarja St., two-way Qalhak, Doktor Shariati St.
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-10-29, 1401/08/07
Ethics committee reference number
IR.IAU.TMU.REC.1401.324

Health conditions studied

1

Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
Z71.3
ICD-10 code description
Dietary counseling and surveillance

Primary outcomes

1

Description
HbA1c
Timepoint
At the beginning of the study (before the intervention) and after 12 weeks
Method of measurement
Blood Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For this group, 2 capsules of 500 mg of cinnamon were prescribed daily for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: For this group, 2 capsules per day of placebo have been prescribed for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Farhikhtegan Hospital
Full name of responsible person
Zahra Sormeili
Street address
in front of the central organization of Islamic Azad University, North of University Square, Satari end
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
farhikhteganhospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Sormeili
Street address
Islamic Azad University of Medical Sciences, Tehran branch , Khagani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Sormeili
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
In front of the central organization of Islamic Azad University, North of University Square, At the end of Sattari
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
zahrasormeili@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Sormeili
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
In front of the central organization of Islamic Azad University, North of University Square,At the end of Sattari
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
zahrasormeili@gmaol.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Sormeili
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
In front of the central organization of Islamic Azad University, North of University Square,At the end of Sattari
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
zahrasormeili@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the low number of samples, this study was not enough to draw conclusions, and for this purpose, a large sample size and more facilities are needed, which was not possible in this research.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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