Determining the effect of cinnamon capsule on the severity of menopausal symptoms
Design
This is a randomized clinical trial study in which 60 eligible individuals will be randomly assigned to the intervention and control groups.
Settings and conduct
Eligible women who refer to the comprehensive health centers of Hamadancity during the study will be randomly assigned to intervention and control groups.
Participants/Inclusion and exclusion criteria
Age range 45 to 60 years, At least one year and at most 3 years have passed since the last menstrual period, Menopause naturally, Score 12 or higher on the Menopause Symptoms Scale
Intervention groups
Intervention group: Cinnamon capsules, once a day, for 2 months
Control group: taking a placebo once a day for 2 months
Main outcome variables
Severity of menopausal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200530047596N2
Registration date:2021-03-02, 1399/12/12
Registration timing:prospective
Last update:2021-03-02, 1399/12/12
Update count:0
Registration date
2021-03-02, 1399/12/12
Registrant information
Name
Mansoureh Refaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
m.refaei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cinnamon capsule on the severity of menopausal symptoms in women covered by comperhensive health centers in Hamadan in 2021
Public title
The effect of cinnamon on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 45 to 60 years
At least one year and at most 3 years have passed since the last menstrual period
Menopause naturally
Score 12 or higher on the Menopause Symptoms Scale
Exclusion criteria:
receiving hormone therapy
history of hysterectomy or oophorectomy
medical or psychological problems
Take any herbal or chemical medicine
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of random allocation will be determined by one of the researchers based on the permutation blocking method in two groups A and B,
using RAS( Random allocation software) software. the determined sequence will be numbered from number one to 60 from beginning to end, respectively. Capsules (cinnamon and placebo) are placed in 60 pieces in similar sealed and opaque envelopes. Then, each number envelope is assigned to the number of samples, ie from 1 to 60. Therefore, only the researcher who made the random assignment knows what drug each envelope contains. The numbered envelopes are then given to another researcher who is unaware of the random allocation process. Then the samples are received in order and the number of envelopes is received, the medicine is received and the envelope number is stated in the questionnaire. Participants will not be informed of the type of group assigned. After collecting the data, the data is entered into the software based on the numbers and groups A and B, and thus the statistical analyst will not be aware of the type of group assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, 60 envelopes with the same matte shape are prepared. Cinnamon capsules in 30 packs and starch capsules in 30 packs. Due to the uniform shape and uniform consumption of the capsules, participants will not be aware of the type of substance used.
On the other hand, the envelopes will be numbered according to the specified sequence from 1 to 60 and will be given to the participants by a researcher who does not know the sequence. The same researcher will then evaluate the consequences. On the other hand, the statistical analyzer will not be aware of the type of intervention groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethic Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.UMSHA.REC.1399.1012
Health conditions studied
1
Description of health condition studied
Menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
The severity of menopausal symptoms
Timepoint
Before the intervention and 2 months after taking the capsules
Method of measurement
Menopause Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants are asked to consume one capsule containing one gram of cinnamon powder daily, which is prepared in the Faculty of Pharmacy of Hamadan University of Medical Sciences, for 2 months.
Category
Treatment - Other
2
Description
Control group: Participants are asked to consume one capsule containing one gram of starch powder daily, which is prepared in the Faculty of Pharmacy of Hamadan University of Medical Sciences, for 2 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive centers of Hamedan
Full name of responsible person
Mansoureh Refaei
Street address
Shahidf Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Email
mansourehrefaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0535
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mansoureh Refaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0535
Email
mansourehrefaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mansoureh Refaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0535
Email
mansourehrefaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mansoureh Refaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0535
Email
mansourehrefaei@yahoo.com
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