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IRCT20100124003146N12 IRCT 2023-11-13 Kashan University of Medical Sciences The Effect of Flower Extract of Elaeagnus Angustifolia on Sexual Functioning in Menopausal Women The Effect of Flower Extract of Elaeagnus Angustifolia on Sexual Functioning in Menopausal Women 2023-11-21 anticipated 68 Complete https://irct.ir/trial/72261 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: The first researcher, the research samples and the statistical analyst will not have any information about the names of the groups. 2 sexual function. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The results of the main outcome will be published. When: Access will start from the time the results are printed to forever. To whom: Academic and industrial researchers are allowed to submit data requests. Conditions: 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. Where to obtain: Dr. Ismail Azizi Fini, email: azizifinies@yahoo.com How to obtain: After sending the request via email, it will be in the shortest time. Comments:
public Ismail Azizi Fini
Kashan university of madical sciences
Kashan Iran (Islamic Republic of) 8715981151 +98 36 1555 0021 azizi-es@kaums.ac.ir Kashan University of Medical Sciences scientific Ismail Azizi-Fini
Ghotb Ravandi Blv- Pezashek Blv
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0021 azizi-es@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 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 50 years 65 years Female 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 E28.310 Symptomatic premature menopause Treatment - Drugs Placebo 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. 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. The sexual performance score of postmenopausal women is less than 28 from the FSFI questionnaire. Timepoint: 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. Method of measurement: Female Sexual Function Index. Anxiety. Timepoint: 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. Method of measurement: Beck Anxiety Inventory. Sleep quality. Timepoint: 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. Method of measurement: Pittsburgh Sleep Quality Index. Number of times of intercourse per month. Timepoint: 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. Method of measurement: Questionnaire (one question about the number of sexual intercourses per month). Kashan University of Medical Sciences Approved 2023-08-19 Ethics committee of Kashan University of Medical Sciences 5th Kilometer Qotb Ravandi Blouvar kashan Isfehan Iran (Islamic Republic of)