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IRCT20240506061682N1 IRCT 2024-06-19 Yasouj University of Medical Sciences Investigating the effect of combined vaginal gel of oak placenta and fennel on sexual function and quality of sexual life of postmenopausal women The effect of combined vaginal gel of Quercus brantii and fennel (Foeniculum vulgare) on the sexual function and quality of sexual life of menopausal women 2024-07-20 anticipated 80 Complete https://irct.ir/trial/76686 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, people will be randomly assigned to two groups of herbal gel and placebo by Computer Random Generation method. The tubes will be coded by the pharmacist using a table of random numbers and noted by the pharmacist, so that each tube has a unique code. Only the pharmacist knows which tube contains gel and which tube contains placebo. Researchers or volunteers participating in the project are covered, Blinding description: Both the menopausal women participating in the project and the researcher related to them are unaware of the exposure received, the tube and box of gel and placebo are offered in a completely similar appearance and packaging, and each has its own code, which is only the pharmacist of the mentioned items. knows. 3 Quality of sexual life and sexual performance. Intervention 1: Intervention group: Each person received a 50-gram tube containing a combined herbal gel of oak (5.2%) and fennel (5%) with an applicator to be used for 8 weeks (one gram every night for the first two weeks, and the next six weeks every other night) will be given. Then the patient will be called to the health center through a phone call. The patient will be taught the duration of use and the follow-up times, and the patients will be asked to return for re-examination and follow-up in the eighth week from the start of treatment. The phone number of the patients will be taken and the method of use and follow-up times will be reminded and it will be emphasized that they should not use any hormonal drugs with other vaginal ingredients. In case of any complications (such as allergy ) after taking the medicine, the intervention will be stopped and complications will be reported. Questionnaires of the quality of sexual life and sexual performance are completed by people before and after the intervention. Intervention 2: Control group: Each person will be given a 50 gram tube containing placebo with an applicator to be consumed for 8 weeks (one gram every night for the first two weeks, and every other night for the next six weeks). Then the patient will be called to the health center through a phone call. The patient will be taught the duration of use and the follow-up times, and the patients will be asked to return for re-examination and follow-up in the eighth week from the start of treatment. The phone number of the patients will be taken and the method of use and follow-up times will be reminded and it will be emphasized that they should not use any hormonal drugs with other vaginal ingredients. In case of any complications (such as allergy ) after taking the medicine, the intervention will be stopped and complications will be reported. Questionnaires of the quality of sexual life and sexual performance are completed by people before and after the intervention. Yes - There is a plan to make this available What will be shared: The research results will be made available to everyone with honesty. When: The research results will be made available to everyone with honesty. To whom: The research results will be made available to everyone with honesty. Conditions: The research results will be made available to everyone with honesty. Where to obtain: The research results will be made available to everyone with honesty. How to obtain: The research results will be made available to everyone with honesty. Comments:
public Sara Nikkhah
Motahari Boulevard
Yasuj Iran (Islamic Republic of) 7591396661 +98 917 664 8896 saranik358@gmail.com Yasouj University of Medical Sciences scientific Sara Nikkhah
Motahari Boulevard
Yasuj Iran (Islamic Republic of) 7591396661 +98 917 664 8896 saranik358@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Passing at least one year since the last menstruation, having a hormone test with an FSH level greater than 40 international units age range of 45-65 years having sex and being monogamous 45 years 65 years Female Rehabilitation Placebo Intervention group: Each person received a 50-gram tube containing a combined herbal gel of oak (5.2%) and fennel (5%) with an applicator to be used for 8 weeks (one gram every night for the first two weeks, and the next six weeks every other night) will be given. Then the patient will be called to the health center through a phone call. The patient will be taught the duration of use and the follow-up times, and the patients will be asked to return for re-examination and follow-up in the eighth week from the start of treatment. The phone number of the patients will be taken and the method of use and follow-up times will be reminded and it will be emphasized that they should not use any hormonal drugs with other vaginal ingredients. In case of any complications (such as allergy ) after taking the medicine, the intervention will be stopped and complications will be reported. Questionnaires of the quality of sexual life and sexual performance are completed by people before and after the intervention. Control group: Each person will be given a 50 gram tube containing placebo with an applicator to be consumed for 8 weeks (one gram every night for the first two weeks, and every other night for the next six weeks). Then the patient will be called to the health center through a phone call. The patient will be taught the duration of use and the follow-up times, and the patients will be asked to return for re-examination and follow-up in the eighth week from the start of treatment. The phone number of the patients will be taken and the method of use and follow-up times will be reminded and it will be emphasized that they should not use any hormonal drugs with other vaginal ingredients. In case of any complications (such as allergy ) after taking the medicine, the intervention will be stopped and complications will be reported. Questionnaires of the quality of sexual life and sexual performance are completed by people before and after the intervention. Questionnaire score of sexual performance. Timepoint: At the beginning of the study and before drug administration and 8 weeks after the start of treatment. Method of measurement: Postmenopausal Women's Sexual Performance Questionnaire (FSFI). Quality of sexual life of menopausal women. Timepoint: At the beginning of the study and before drug administration and 8 weeks after the start of treatment. Method of measurement: Women's Quality of Life Questionnaire (SQOL-F). Sexual desire. Timepoint: At the beginning of the study before drug administration and also after treatment. Method of measurement: Questionnaire of sexual function of postmenopausal women. Orgasm. Timepoint: At the beginning of the study before drug administration and also after treatment. Method of measurement: Questionnaire of sexual function of postmenopausal women. Stimulation. Timepoint: At the beginning of the study before drug administration and also after treatment. Method of measurement: Questionnaire of sexual function of postmenopausal women. Get wet. Timepoint: At the beginning of the study before drug administration and also after treatment. Method of measurement: Questionnaire of sexual function of postmenopausal women. Satisfaction. Timepoint: At the beginning of the study before drug administration and also after treatment. Method of measurement: Questionnaire of sexual function of postmenopausal women. The pain. Timepoint: At the beginning of the study before drug administration and also after treatment. Method of measurement: Questionnaire of sexual function of postmenopausal women. Yasouj University of Medical Sciences Approved 2024-04-27 Ethics Committee of Yasouj University of Medical Sciences Qorani Blvd./ Shahid Dehrabpur St./ Corner of Jhanbazan 8 yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)