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comparison of the effect of cinnamon and vitex oral capsules on sexual function in postmenopausal women coverd by selected health centers affiliated to shahid beheshti university of medical sciences in 2019

Protocol summary

Study aim
Main goal: Investigating the effect of cinnamon and vitex-agnus capsule on improving the sexual function of postmenopausal women Objective goal: Improving the sexual function of postmenopausal women without the need for hormonal drugs
Design
triple blind clinical trial
Settings and conduct
North Tehran Health Centeres
Participants/Inclusion and exclusion criteria
1. Be Iranian. 2. Have at least literacy. 3. Do not have speech, hearing or mental disorders that prevent communication with the researcher. 4. It's been at least a year since they stopped menstruating. 5. Have a married life with your spouse. 6. There is no inclination or obligation to use hormone replacement therapy. 7. According to Ms. Menopause, do not use any chemical or herbal remedies to treat your problem. 8. Have sex. 9. A postmenopausal wife does not have a sexual problem.
Intervention groups
Intervention group: Active drug control group: placebo
Main outcome variables
sexual function, and its domains include: desire, arousal, lubrication, orgasm, satisfaction, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200504047299N1
Registration date: 2020-07-08, 1399/04/18
Registration timing: retrospective

Last update: 2020-07-08, 1399/04/18
Update count: 0
Registration date
2020-07-08, 1399/04/18
Registrant information
Name
Tanya Koliji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4244 6875
Email address
tanipaezan.koliji@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-29, 1398/11/09
Expected recruitment end date
2020-06-29, 1399/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of cinnamon and vitex oral capsules on sexual function in postmenopausal women coverd by selected health centers affiliated to shahid beheshti university of medical sciences in 2019
Public title
comparison of the effect of cinnamon and vitex oral capsules on sexual function in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Be Iranian. 2. Have at least literacy. 3. Do not have speech, hearing or mental disorders that prevent communication with the researcher. 4. It's been at least a year since they stopped menstruating. 5. Have a married life with her spouse. 6. There is no inclination or obligation to use hormone replacement therapy. 7. As menopausal woman sated, do not use any chemical or herbal remedies to treat her problem. 8. Have sexual activity. 9. A postmenopausal wife does not have a sexual problem. 10. They have not undergone hysterectomy and ovariectomy, cystocele, rectocele, and mastectomy. 11. Menopausal women and their spouses do not have a known mental illness. 12. Not addicted to cigarettes or drugs. 13. He has not recently used antidepressants drugs. 14. Have no history of known chronic diseases such as high blood pressure, diabetes, asthma, weaken the immune system, etc. 15. Has no history of allergy to medicinal plants. 16. Do not use herbal teas during medication. 17. Age between 45 and 65 years
Exclusion criteria:
1. Possible sensitivity to capsules 2. Do not take the capsule for a week or more 3. Lack of desire to continue treatment
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers were used to randomize and assign individuals to groups; randomization using Excel software is as follows: First, in a column, groups are entered as A, B, c, and below, because the number of samples in each group is set to 35 (including the sample fall), so 35, B, A c must be as follows. And they come in regularly. In the opposite column, random numbers are generated using the RAND command. In the next step, using the sort command, random numbers generated from small to large or vice versa are arranged, which causes the order of the groups, c, A, B, to change. Using the new order, people are assigned to different groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a randomized triple-blind clinical trial, meaning that the researcher, research sample, and statistical consultant professor are unaware of what drugs each group is taking, or which of the A, B or C envelopes contain which drugs.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti university of medical science
Street address
No. 58, Raees zadeh St., Tehran villa Ave., Satarkhan14
City
tehran
Province
Tehran
Postal code
۱۴۴۴۷۳۴۷۷۹
Approval date
2019-12-10, 1398/09/19
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.243

Health conditions studied

1

Description of health condition studied
اختلال کارکرد جنسی
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
Sexual dysfunction according to the FSFI questionnaire
Timepoint
Before intervention, 2 month after intervention, 3 month after intervention
Method of measurement
FSFI questionnaire

Secondary outcomes

1

Description
Sexual desire
Timepoint
Before intervention, 2 month after intervention, 3 moth after intervention
Method of measurement
The Female Sexual Function Index (FSFI) questionnaire

2

Description
Sexual satisfaction
Timepoint
Before intervention, 2 month after intervention, 3 month after intervention
Method of measurement
The Female Sexual Function Index (FSFI) questionnaire

3

Description
Orgasm
Timepoint
Before intervention, 2 month after intervention, 3 month after intervention
Method of measurement
The Female Sexual Function Index (FSFI) questionnaire

4

Description
Arousal
Timepoint
Before intervention, 2 month after intervention, 3 month after intervention
Method of measurement
The Female Sexual Function Index (FSFI) questionnaire

5

Description
Lubrication
Timepoint
Before intervention, 2 month after intervention, 3 month after intervention
Method of measurement
The Female Sexual Function Index (FSFI) questionnaire

6

Description
Pain during intercourse
Timepoint
Before intervention, 2 month after intervention, 3 month after intervention
Method of measurement
The Female Sexual Function Index (FSFI) questionnaire

Intervention groups

1

Description
The intervention group is menopausal women, which will be divided into two groups: oral cinnamon capsules (400 mg) and vitex-agnus capsules (400 mg). The capsules will be provided at the School of Pharmacy of Shahid Beheshti University of Medical Sciences, and postmenopausal women will take 2 capsules a day for 2 months.
Category
Treatment - Drugs

2

Description
The control group is menopausal women who will receive placebo capsules. These capsules were prepared in the Faculty of Pharmacy in Shahid Beheshti University of Medical Sciences and were matched with cinnamon capsules and vitex-agnus in terms of appearance. Samples take 2 of these capsules for 2 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
North Tehran Health Cnteres
Full name of responsible person
Dr. Nemat alah Mohammadi Nia
Street address
No. 2/16., Eshraghi Ave., shariati St.
City
Tehran
Province
Tehran
Postal code
1444734779
Phone
+98 21 8851 1361
Email
mbsh@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Simbar
Street address
Valiasr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Nursing and Midwifery Faculty
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tanya Koliji
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 58., Raees zade Ave., Tehran villa St., Satarkhan
City
Tehran
Province
Tehran
Postal code
1444734779
Phone
+98 21 6652 0143
Email
tanipaezan.koliji@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Zare
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 58., Raees zade Ave., Tehran Villa St., Satarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۴۷۳۷۷۹
Phone
+98 21 6652 0143
Email
elhamzare.phd@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tanya Koliji
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 58., Raees zade Ave., Tehran villa St., Starkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۴۷۳۴۷۷۹
Phone
+98 21 6652 0143
Email
tanipaezan.koliji@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the consequences will be shared
When the data will become available and for how long
3 month after outcomes
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to perform more accurate clinical trials
From where data/document is obtainable
Nursing and Midwifery Faculty of Shahid beheshti university of medical science
What processes are involved for a request to access data/document
It will be available as soon as possible after requesting information
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