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IRCT20230831059313N1 IRCT 2023-11-02 Shahid Beheshti University of Medical Sciences Investigating the effect of Melissa officinalis capsule on the sexual function of Menopause women Investigating the effect of Melissa officinalis capsule on the sexual function of Menopause women 2023-10-22 anticipated 100 Complete https://irct.ir/trial/72386 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, in order to select health service centers, the researcher needs to select four centers by simple random sampling. Random numbers function of Excel software is used to randomize the samples into intervention and control groups. to this extent, the numbers represented the samples are sorted from 1 to 100 then written in order in the first column and in the next column, the numbers 1 and 2 are randomly placed in front of each sample. Finally, the samples are divided into two groups in the same order as they enter the study, Blinding description: This study is a triple-blind randomized clinical study. Therefore, the researcher, the research units, and the statistics consultant professor are not aware of the coding and what sort of medicine each package contains and only the pharmaceutical consultant of the research is aware of the coding of the envelopes and the type of drugs. 3 Sexual function of Menopause women. Intervention 1: Intervention group: In this research, the intervention group consumes Melissa capsules. These capsules contain 500 mg of Melissa plant extract powder. These capsules are prepared in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. In this way, the purchased plant is extracted by the pharmaceutical consultant. It is made into a powder and poured into capsules similar to a placebo and one capsule per day is consumed by a menopausal woman for two months. Intervention 2: Control group: In this study, the control group uses a placebo. Placebo means edible capsules containing dry bread powder And these capsules are adapted to Melissa capsules in terms of shape and size. They are prepared in the laboratory of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences, by the pharmaceutical consultant professor. also, the capsules are placed along side to each other so that they smell similar and then they are provided to the samples in similar envelopes. One capsule is taken daily for two months by a menopausal women. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Hamide Ahmadi
Shahid Beheshti School of Nursing and Midwifery, The intersection of Hashemi Rafsanjani highway and Valiasr street
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8820 2518 hamide.ahmadi1990@gmail.com Shahid Beheshti University of Medical Sciences scientific Elham Zare
Shahid Beheshti School of Nursing and Midwifery, The intersection of Hashemi Rafsanjani highway and Valiasr street
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 elhamzare.phd@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Be Iranian. At least be literate in reading and writing. At least one year has passed since their menopause. Have a married life with her husband. Not willing or required to use hormone replacement therapy. According to Miss Menopause don't use any chemical or herbal medicine to treat your problem. have sexual activity. Do not use herbal teas while taking medicines. no limit no limit Female Have speech, hearing or mental disorders that prevent communication with the researcher. Have undergone hysterectomy and ovariectomy, cystocele and rectocele, and mastectomy. Have a history of known chronic diseases such as high blood pressure, diabetes, asthma, weakening the immune system, etc. Her husband of a menopausal woman have sexual problems. Menopausal women and their husbands are known to have mental illness. Addicted to smoking or drugs. A special event or incident that constitutes a crisis in their life, such as the death of a loved one, incurable illness in family members, change of residence, loss of job has occurred since 6 months ago. Have a history of allergy to medicinal plants. Have a history of endometrial cancer and other estrogen-related cancers in first-degree relatives. Have a history of gluten sensitivity. Treatment - Drugs Placebo Intervention group: In this research, the intervention group consumes Melissa capsules. These capsules contain 500 mg of Melissa plant extract powder. These capsules are prepared in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. In this way, the purchased plant is extracted by the pharmaceutical consultant. It is made into a powder and poured into capsules similar to a placebo and one capsule per day is consumed by a menopausal woman for two months. Control group: In this study, the control group uses a placebo. Placebo means edible capsules containing dry bread powder And these capsules are adapted to Melissa capsules in terms of shape and size. They are prepared in the laboratory of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences, by the pharmaceutical consultant professor. also, the capsules are placed along side to each other so that they smell similar and then they are provided to the samples in similar envelopes. One capsule is taken daily for two months by a menopausal women. Sexual function score in female sexual function index questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Female Sexual Function Index Questionnaire. Sexual satisfaction score. Timepoint: Before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: ّFemale sexual Function Index Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-08-01 Ethics Committee of Schools of Pharmacy, Midwifery Nursing - Shahid Beheshti University of Medical S 13th floor, Block A, Headquarters of Ministry of Health, Treatment and Medical Education, Simai Iran St, between South Flamak and Zarafshan, Quds town (west), Tehran Tehran Tehran Iran (Islamic Republic of)