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IRCT20230723058892N1 IRCT 2023-08-30 Mashhad University of Medical Sciences The effects of myrtus communis on Sexual Function The effects of vaginal gel of myrtus communis on Sexual Function of married women during Reproductive Ages 2023-08-23 anticipated 76 Complete https://irct.ir/trial/71634 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The necessary sample is selected in an easy and accessible way, and then the permutation block method is used to generate the sequence of random allocation of people to the studied groups. Random allocation sequence of people will be done using Random Allocation Software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of studied groups. There are six blocks in this study. One of the blocks is randomly selected. If the first block is AABB, the first and second people will be assigned to group A, and the third and fourth people will be assigned to group B, and this process continues until all the samples will be assigned. The characteristic of this method is that the two study groups will have equal numbers, Blinding description: The study is a triple-blind randomized clinical trial. That is, the researcher, the research unit and the statistical consultant do not know the type of drug given (vaginal gel or placebo).The gel is made with a completely identical appearance to the placebo. 2-3 Sexual function and sexual dysfunction. Intervention 1: Intervention group: This group includes 38 people who will use an applicator of 5% case leaf vaginal gel, 15 minutes before sexual intercourse for 4 weeks. Intervention 2: Control group:This group included 38 people who used a placebo applicator 15 minutes before sexual intercourse for 4 weeks. 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 In the next stages of the research, a decision will be made about this.
public raheleh babazadeh
Mashhad Faculty of Nursing and Midwifery, Ibn-e Sina St.,Doktora Crossing, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 babazadehr@mums.ac.ir Mashhad University of Medical Sciences scientific Raheleh Babazadeh
Mashhad Faculty of Nursing and Midwifery; Ibn-e Sina street; Doktora crossroads
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 babazadehr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) A married woman of reproductive age (18-40) years old Having informed consent to participate in the research Having a sexual function score based on the FSFI questionnaire is less than 28 Has a history of NVD Having sex at least once a week A resident of Mashhad or the suburbs Having at least reading and writing literacy Having a regular period cycle (26-32 days) and not having AUB Having a depression score of less than 21, anxiety less than 15, and stress less than 26 in the DASS questionnaire 18 years 40 years Female Allergy to herbal substances or herbs pregnancy and breastfeeding infertility hormone therapy or use of sex hormones 2 months before the study Specific mental illness in couples and specific medical illness affecting sexual function in women and husbands vaginal atrophy Pelvic radiation therapy or chemotherapy to treat cancer oophorectomy early menopause uncontrolled diabetes Treatment with drugs used to reduce estrogen levels in women with endometriosis F52 Sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Treatment - Drugs Intervention group: This group includes 38 people who will use an applicator of 5% case leaf vaginal gel, 15 minutes before sexual intercourse for 4 weeks. Control group:This group included 38 people who used a placebo applicator 15 minutes before sexual intercourse for 4 weeks. Sexual function score in the FSFI questionnaire. Timepoint: Measurement of sexual function at the beginning of the study (before the start of the intervention) and 4 weeks after using the vaginal gel. Method of measurement: Female Sexual Function Index Questionnaire. Mashhad University of Medical Sciences Approved 2023-07-22 Ethics Committee of Mashhad University of Medical Sciences Baharestan dormitory 2; Medical Sciences Campus; Bahonar Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)