Determining the effect of a combination of saffron and cinnamon on the severity of menopausal symptoms and fatigue in postmenopausal women
Design
A phase II randomized, double-blind, parallel-group, controlled clinical trial was conducted on 64 participants. Randomization was performed using the RAND function in Microsoft Excel
Settings and conduct
Participants are randomly assigned to the two groups of 32 recipients of capsule of cinnamon-saffron extract and placebo group.This study will be conducted in Comprehensive Health Centers of Hamadan city. In this study, neither the researcher nor the menopausal women knows the contents of the package and double blinded will be performed. In intervention group, Capsule of cinnamon-saffron extract and in Control group, placebo will be prescribed Twice in a day along two months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 45-55 years, at least 1 year after menopause (12 months after cessation of menstruation), no smoking or alcohol consumption, no mental or physical illness, no use of relaxation techniques, no use of herbal and hormonal treatments at least 3 months before the intervention
Exclusion criteria: Failure to complete the course of treatment
Intervention groups
Intervention group: Capsule of cinnamon-saffron extract will be prescribed in the form of Oral Capsule 1000 mg, once a day for 6 weeks. This drug will be produced by Hamadan University of Medical Sciences. Control group: placebo will be prescribed in the form of Oral Capsule contain of Starch 1000 mg once a day for 6 weeks. Placebo is made by Hamadan University of Medical Sciences.
Main outcome variables
Menopausal symptoms; fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120821010635N4
Registration date:2026-02-07, 1404/11/18
Registration timing:prospective
Last update:2026-02-07, 1404/11/18
Update count:0
Registration date
2026-02-07, 1404/11/18
Registrant information
Name
Soodabeh Aghababaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
aghababaii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-01, 1404/12/10
Expected recruitment end date
2026-08-01, 1405/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cinnamon and Saffron on menopause symptoms and fatigue among menopausal women
Public title
The effect of Cinnamon and Saffron on menopause symptoms and fatigue among menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45-55 years
At least 1 year after menopause (12 months after cessation of menstruation)
No smoking or alcohol consumption
No physical or mental illness
No use of relaxation techniques
No use of herbal and hormonal treatments at least 3 months before the intervention
Exclusion criteria:
Failure to complete the course of treatment
Age
From 45 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly selected by (rand between (1; 2)) command, in the Excel computer program that are assigned to the two groups of 32 recipients of capsule of Cinnamon-Saffron extract and placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug packages are similar and were given to menopausal women by other person. This person does not inform about the package contents. therefore, neither the researcher nor the menopausal women knows the contents of the package and double blinding will be performed.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan Uiniversity of medical sciences, Shahid Fahmideh Ave, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۸
Approval date
2026-01-24, 1404/11/04
Ethics committee reference number
IR.UMSHA.REC.1404.895
Health conditions studied
1
Description of health condition studied
Hot flashes
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Menopausal symptoms
Timepoint
Before the start of the intervention, 3 weeks and 6 weeks after the end of the intervention
Method of measurement
Menopausal Rating Score
Secondary outcomes
1
Description
Fatigue
Timepoint
Before the start of the intervention, 3 and 6 weeks after the end of the intervention
Method of measurement
Fatigue Severity Scale
Intervention groups
1
Description
Intervention group: Capsule of Cinnamon-Saffron extract will be prescribed in the form of Oral Capsule 1000 mg, once a day for 6 weeks. Hamadan University of Medical Sciences will produce this drug.
Category
Treatment - Drugs
2
Description
Control group: Placebo will be prescribed in the form of an oral capsule containing starch 1000 mg, once a day, for 6 weeks. The placebo is made in Hamadan University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomini Health center
Full name of responsible person
Soodabeh Aghababaei
Street address
Shahid Beheshti town
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۸
Phone
+98 81 3827 6139
Email
Emamkomini.health@yahoo.com
2
Recruitment center
Name of recruitment center
Comprehensive Health Service Center of Shohada
Full name of responsible person
Soodabeh Aghababaei
Street address
Comprehensive Health Service Center of Shohada., Takhti Ave., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838344
Phone
+98 81 3252 4321
Email
Shohada.health@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Alireza Soltanian
Street address
Shahid Fahmideh Ave, Hamadan.
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۸۴
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Web page address
https://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
Soodabeh Aghababaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۸
Phone
+98 81 3838 0535
Email
aghababaii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Soodabeh Aghababaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۸
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
aghababaii@yahoo.com
Web page address
https://midnurse.umsha.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Aghababaei Soodabeh
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmideh Ave, Hamadan Medical Sceinces University, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۸
Phone
+98 81 3838 0150
Fax
Email
aghababii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data analysis is permitted with the author's permission.
From where data/document is obtainable
Hamadan University of Medical Sciences
What processes are involved for a request to access data/document