Effect of oral cinnamon supplementation on blood pressure in individuals with stage 1 hypertension
Design
A randomized, placebo-controlled, double-blind clinical trial
Settings and conduct
In this double-blind clinical trial study, new hypertensive patients referred to Imam Reza Hospital Clinic, Mashhad, Iran, with systolic pressure between 130-139 mmhg and or diastolic blood pressure 80-89 mmhg without receiving any anti hypertensive drug, are selected and confirmed by 24-hour Holter monitoring of the blood pressure. Patients are randomly divided into two groups of cinnamon and placebo.Patients in the intervention group are given three capsules of 500 mg cinnamon daily. Written informed consent is obtained from these patients. Lipid profile, fasting blood sugar and systolic and diastolic blood pressure are measured at baseline and 90 days after the start of the trial (end of the study). At the end of the study, patients will be re-tested under 24-hour blood pressure monitoring.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals of 40-79 years old, having systolic blood pressure of 139-130 mmhg and or diastolic blood pressure 80-89 mmhg (as measured in the office and confirmed by 24-hour Holter monitoring of the blood pressure ).Exclusion criteria: presence of end organ damage during the last 6 months, secondary hypertension, pregnancy and lactation, patients receiving any type of antihypertensive medication.
The effect of cinnamon supplementation on blood pressure in patients with stage 1 hypertension
Public title
The effect of cinnamon supplementation on blood pressure in patients with stage1 hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are a new case of systolic hypertension (139-130 mmhg) and or diastolic hypertension (89-80 mmhg)
being 40-79 years old
10-year cardiovascular risk less than 10%
Exclusion criteria:
Symptoms of end organ damage
arbitrary discontinuation of medication,
secondary causes of hypertension,
pregnancy and lactation
patients receiving any type of antihypertensive medication
failure to cooperate till the end of the study
complications of cinnamon
diabetes
Age
From 40 years old to 79 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using random number extraction software, a list of number is obtained; based on the random-numbers list, participants are divided into two groups to receive either placebo or cinnamon.
Blinding (investigator's opinion)
Double blinded
Blinding description
Cinnamon and placebo will be purchased and given to the research unit. Both containers of cinnamon and placebo are quite similar in appearance and will be labeled as A or B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah
City
Mashhad
Province
Razavi Khorasan
Postal code
9179943835
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.577
Health conditions studied
1
Description of health condition studied
HYPERTENSION
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
HYPERTENSION
Timepoint
At baseline and 90 days later
Method of measurement
24-hour blood pressure monitoring using Holter
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
The first day of study and 90days after the start
Method of measurement
mg/dl
2
Description
Body max index
Timepoint
The first day of study and 90days after the start
Method of measurement
Kg/m2
3
Description
lipid profile
Timepoint
The first day of study and 90days after the start
Method of measurement
mg/ dl
Intervention groups
1
Description
500 mg Cinnamon Capsule 3 times daily for 90 days
Category
Treatment - Drugs
2
Description
Control group: 500 mg placebo capsule 3 times daily for 90 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Alireza Abdollahi Moghadam
Street address
Emam Reza Hospital ,Emam Reza Squre ,Ebne-Sina Street ,Mashhad ,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۹۴۳۸۳۵
Phone
+98 51 3854 3031
Email
f.sh8844@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Abdollah Moghadam
Street address
Cardiology Department ,Imam Reza Hospital ,Imam Reza Square ,Ebne-Sina Street , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9179943835
Phone
+98 51 3854 3031
Email
Abdollahiar@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Shirzad Shahraki
Position
Cardiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Cardiology department , Imam Reza hospital , Imam Reza Square , Ebne-sina Street , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۹۴۳۸۳۵
Phone
+98 51 3502 4881
Email
F.sh8844@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Abdollah Moghadam
Position
Cardiologist
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Cardiology department , Imam Reza hospital , Imam Reza Square , Ebne-sina Street , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۹۴۳۸۳۵
Phone
+98 51 3502 4881
Email
Abdollahiar@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Shirzad
Position
Cardiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Cardiology department , Imam Reza Hospital , Imam Reza Square , Ebne-Sina Street , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۹۴۳۸۳۵
Phone
+98 51 3502 4884
Email
F.f.sh8844@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available