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IRCT20250417065363N1 IRCT 2025-05-15 Shahid Beheshti University of Medical Sciences The effect of Phenalis oral capsules on sexual function and satisfaction in postmenopausal women. Study and comparison of the effect of a combined oral capsule containing lemon balm and fennel on sexual function and sexual satisfaction in postmenopausal women 2025-05-05 anticipated 88 Complete https://irct.ir/trial/82970 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling is done conveniently based on the study entry criteria and the samples are assigned to the control and intervention groups by simple randomization method based on a randomization list. The randomization list is prepared using R software and will be given confidentially by the statistical consultant to the pharmacist, Blinding description: After grouping the samples into the sample and control groups, assigning a code to each individual, and coding the medication packets, the pharmacist will hand over the coded medication packets to the researcher and the intervention will begin. Coding will be done by the pharmacist in the laboratory of Shahid Beheshti Faculty of Medicine. Therefore, the researcher, the research samples, and the statistical consultant will not know the contents of the packets. 3 Sexual function and sexual satisfaction. Intervention 1: Intervention group: Oral capsule containing fennel and lemon balm. Manufactured by the Traditional Medicine and Medical Supplies Research Center of Shahid Beheshti University of Medical Sciences. The capsule contains 2 grams of fennel extract (in powder form) and 2 grams of lemon balm extract (in powder form). The samples should take 2 capsules daily, one on an empty stomach and the other before bedtime, for two consecutive months. Intervention 2: Control group: Control group: Oral capsule containing starch powder. (The control capsule package has the same color,smell and shape as the medicine) Manufactured by the Traditional Medicine and Medical Supplies Research Center, Shahid Beheshti University of Medical Sciences. The method and duration of placebo consumption is also similar to the original drug. (Two capsules daily, one on an empty stomach and one before bedtime for 2 consecutive months). No - There is not a plan to make this available Justification or reason for not sharing IPD is Because the data was collected under specific conditions for the thesis, it cannot be used in other studies.
public Shamim Naghibinezhad
NO. 61 ,North ABOUZAR GHAFARI Ave, SEYYED KHANDAN Blvd
Tehran Iran (Islamic Republic of) 1661746665 +98 21 2670 2259 sh.naghibinezhad@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Shamim Naghibinezhad
NO. 61 ,North ABOUZAR GHAFARI Ave, SEYYED KHANDAN Blvd
Tehran Iran (Islamic Republic of) 1661746665 +98 21 2670 2259 sh.naghibinezhad@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Be Iranian. Must be at least literate. Not have hearing, speech, or mental disorders that prevent communication with the researcher. At least one year has passed since their menstruation stopped. Do not use herbal teas while taking the medication. Not wanting or needing to use hormone replacement therapy. she doesnt use chemical or herbal medicine for their treatment. Postmenopausal women and their partners should be sexually active. The husband of a menopausal woman, according to her statements, does not have sexual dysfunction (erectile dysfunction, ejaculation). she has not undergone hysterectomy, oophorectomy, cystocele, rectocele, or mastectomy. Postmenopausal women and their spouses (self-reported spouses) should not have a known mental illness. Not be addicted to cigarettes or drugs. Have not recently used antidepressants or anti-anxiety medications. They should not have a history of known chronic diseases such as diabetes, high blood pressure, asthma, immune system disorders, etc. There should be no specific event or incident that constitutes a crisis in their lives, such as the death of a loved one, a terminal illness in a family member, or a change of residence. Have no history of allergy to medicinal plants. 45 years no limit Female Possible side effects of the capsules Unwillingness to continue treatment, such as stopping taking the capsule for 3 consecutive days or a non-consecutive week. Treatment - Drugs Placebo Intervention group: Oral capsule containing fennel and lemon balm. Manufactured by the Traditional Medicine and Medical Supplies Research Center of Shahid Beheshti University of Medical Sciences. The capsule contains 2 grams of fennel extract (in powder form) and 2 grams of lemon balm extract (in powder form). The samples should take 2 capsules daily, one on an empty stomach and the other before bedtime, for two consecutive months. Control group: Control group: Oral capsule containing starch powder. (The control capsule package has the same color,smell and shape as the medicine) Manufactured by the Traditional Medicine and Medical Supplies Research Center, Shahid Beheshti University of Medical Sciences. The method and duration of placebo consumption is also similar to the original drug. (Two capsules daily, one on an empty stomach and one before bedtime for 2 consecutive months) Sexual function score in Female Sexual Function Index questionnaire. Timepoint: At the beginning of the study, 2 and 3 months after the end of the intervention. Method of measurement: Women's Sexual Function Index Questionnaire. Sexual satisfaction score on the Larson Sexual Satisfaction Questionnaire. Timepoint: At the beginning of the study, 2 and 3 months after the end of the intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire(LSSQ). Shahid Beheshti University of Medical Sciences Approved 2024-05-27 Research Ethics Committee of the Faculties of Pharmacy, Nursing and Midwifery, Shahid Beheshti Unive Faculty of Nursing and Midwifery,Ayatollah Hashemi Rafsanjani Highway Intersection,Vali Asr Street.Tehran Town. Tehran Tehran Iran (Islamic Republic of)