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IRCT20200504047299N1 IRCT 2020-07-08 Shahid Beheshti University of Medical Sciences comparison of the effect of cinnamon and vitex oral capsules on sexual function in postmenopausal women 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 2020-01-29 anticipated 105 Complete https://irct.ir/trial/47716 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 اختلال کارکرد جنسی. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Information about the consequences will be shared When: 3 month after outcomes To whom: Researchers working in academic and scientific institutions Conditions: In order to perform more accurate clinical trials Where to obtain: Nursing and Midwifery Faculty of Shahid beheshti university of medical science How to obtain: It will be available as soon as possible after requesting information Comments:
public Tanya Koliji
No. 58., Raees zade Ave., Tehran villa St., Satarkhan
Tehran Iran (Islamic Republic of) 1444734779 +98 21 6652 0143 tanipaezan.koliji@gmail.com Shahid Beheshti University of Medical Sciences scientific Elham Zare
No. 58., Raees zade Ave., Tehran Villa St., Satarkhan
Tehran Iran (Islamic Republic of) ۱۴۴۴۷۳۷۷۹ +98 21 6652 0143 elhamzare.phd@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 45 years 65 years Female 1. Possible sensitivity to capsules 2. Do not take the capsule for a week or more 3. Lack of desire to continue treatment F52 Sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Placebo 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. 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. Sexual dysfunction according to the FSFI questionnaire. Timepoint: Before intervention, 2 month after intervention, 3 month after intervention. Method of measurement: FSFI questionnaire. Sexual desire. Timepoint: Before intervention, 2 month after intervention, 3 moth after intervention. Method of measurement: The Female Sexual Function Index (FSFI) questionnaire. Sexual satisfaction. Timepoint: Before intervention, 2 month after intervention, 3 month after intervention. Method of measurement: The Female Sexual Function Index (FSFI) questionnaire. Orgasm. Timepoint: Before intervention, 2 month after intervention, 3 month after intervention. Method of measurement: The Female Sexual Function Index (FSFI) questionnaire. Arousal. Timepoint: Before intervention, 2 month after intervention, 3 month after intervention. Method of measurement: The Female Sexual Function Index (FSFI) questionnaire. Lubrication. Timepoint: Before intervention, 2 month after intervention, 3 month after intervention. Method of measurement: The Female Sexual Function Index (FSFI) questionnaire. Pain during intercourse. Timepoint: Before intervention, 2 month after intervention, 3 month after intervention. Method of measurement: The Female Sexual Function Index (FSFI) questionnaire. Shahid Beheshti University of Medical Sciences Approved 2019-12-10 Ethics committee of shahid beheshti university of medical science No. 58, Raees zadeh St., Tehran villa Ave., Satarkhan14 tehran Tehran Iran (Islamic Republic of)