Protocol summary
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Study aim
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Determining the effect of elder flower extract on sexual function of postmenopausal women
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Design
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Clinical trial with control group, with parallel groups, three-blind, randomized, phase 2 on 68 patients. Sealedenvelope software was used for randomization.
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Settings and conduct
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The samples taken from the health centers of Kashan city are randomly assigned to two control and test groups. The intervention group will receive the drug and the control group will receive the placebo within the specified period. The questionnaire is reviewed at the beginning, end and one month after the end of the intervention. The first researcher (the drugs will be placed in the same packages and will be marked with a code), the research samples and the statistical analyst (the names of the groups will be recorded in SPSS with abbreviations) will not have any information about the names of the groups.
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Participants/Inclusion and exclusion criteria
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Entry: married postmenopausal women aged 50 to 65 years. Getting a score less than 28 from the questionnaire of women's sexual performance. lack of medical prohibition and lack of treatment and drugs affecting sexual performance; Exit: Loss of the sample or her spouse during the study. Not taking medicine for 4 consecutive days. The individual's unwillingness to continue participating in the study.
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Intervention groups
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The intervention group received hydroalcoholic extract of elderflower and the control group received corn starch in the form of 1000 mg capsules twice a day (1 every 12 hours) for 35 days. These capsules did not differ from each other in appearance.
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Main outcome variables
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sexual function
General information
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Reason for update
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Reason for updating the profile and request from a foreign journal to update the exact sampling time
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100124003146N12
Registration date:
2023-11-13, 1402/08/22
Registration timing:
prospective
Last update:
2025-07-31, 1404/05/09
Update count:
1
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Registration date
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2023-11-13, 1402/08/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-21, 1402/08/30
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Expected recruitment end date
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2024-01-20, 1402/10/30
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Actual recruitment start date
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2023-11-21, 1402/08/30
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Actual recruitment end date
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2024-01-20, 1402/10/30
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Trial completion date
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2024-01-20, 1402/10/30
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Scientific title
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The Effect of Flower Extract of Elaeagnus Angustifolia on Sexual Functioning in Menopausal Women
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Public title
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The Effect of Flower Extract of Elaeagnus Angustifolia on Sexual Functioning in Menopausal Women
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
being married
Being Iranian
Getting a score of less than 28 on the questionnaire on women's sexual performance index
over 55 years old
Having regular sex with your spouse
Menopause diagnosed by a gynecologist
No history of uterine or breast cancer
Not being treated with chemotherapy or radiotherapy
Exclusion criteria:
Unwillingness to participate in the study
Taking antidepressants or drugs related to sexual performance
having cognitive impairment based on the MMSE questionnaire (cutoff point 19)
Having a medical prohibition to have sex for the spouse, such as heart attacks or heart failure
A person suffering from chronic and active diseases that prevent sexual intercourse
Hormone therapy (estrogen, progesterone, testosterone) in the last month
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Age
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From 50 years old to 65 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
68
Actual sample size reached:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The samples will be randomly placed in two groups (test: A and control: B) based on the list prepared from the online randomization software and the address https://www.sealedenvelope.com/simple-randomiser/v1/lists . Random blocks of 4 will be selected.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The first researcher, the research samples and the statistical analyst will not have any information about the names of the groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-08-19, 1402/05/28
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1402.030
Health conditions studied
1
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Description of health condition studied
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sexual function
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ICD-10 code
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E28.310
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ICD-10 code description
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Symptomatic premature menopause
Primary outcomes
1
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Description
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The sexual performance score of postmenopausal women is less than 28 from the FSFI questionnaire
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Timepoint
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At the beginning of the study (before the start of the intervention), the end of the intervention (35 days), one month after the end of the intervention
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Method of measurement
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Female Sexual Function Index
Secondary outcomes
1
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Description
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Anxiety
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Timepoint
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At the beginning of the study (before the start of the intervention), the end of the intervention, one month after the end of the intervention
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Method of measurement
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Beck Anxiety Inventory
2
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Description
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Sleep quality
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Timepoint
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At the beginning of the study (before the start of the intervention), the end of the intervention, one month after the end of the intervention
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Method of measurement
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Pittsburgh Sleep Quality Index
3
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Description
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Number of times of intercourse per month
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Timepoint
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At the beginning of the study (before the start of the intervention), the end of the intervention, one month after the end of the intervention
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Method of measurement
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Questionnaire (one question about the number of sexual intercourses per month)
Intervention groups
1
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Description
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Intervention group: In this study, the hydroalcoholic extract of elderflower will be prepared in Asha Medicinal Herbs Trading Company, which will be purchased after the approval of the plan by the ethics committee and will be prepared in 1000 mg capsules and will be provided to the research units by a gynecologist.
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Category
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Treatment - Drugs
2
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Description
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Control group: Postmenopausal women who are randomly assigned to the control group will receive 1000 mg capsules containing corn starch (manufactured by Tardak Company (1 piece every 12 hours) for 35 days, which has no difference in appearance with elderflower extract.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The results of the main outcome will be published.
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When the data will become available and for how long
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Access will start from the time the results are printed to forever.
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To whom data/document is available
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Academic and industrial researchers are allowed to submit data requests.
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Under which criteria data/document could be used
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The applicant must first clearly state the purpose of the data request to the person in charge, and if approved by the university's research council, non-identifiable data will be provided to him.
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From where data/document is obtainable
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Dr. Ismail Azizi Fini, email: azizifinies@yahoo.com
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What processes are involved for a request to access data/document
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After sending the request via email, it will be in the shortest time.
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Comments
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