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IRCT20200511047404N1 IRCT 2020-06-04 Ahvaz University of Medical Sciences The Effect of Quercus (Oak Gal) on Pelvic Floor Muscle and Sexual Function in Post- Menopausal Women The Effect of Vaginal gel of Quercus (Oak Gal) on Pelvic Floor Muscle’s Strength and Sexual Function in Post- Menopausal Women 2020-06-21 anticipated 100 Complete https://irct.ir/trial/48154 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Preparation of vaginal gel of oak Gall by pharmacist It will be built in the laboratory of Ahvaz School of Pharmacy. In order to reduce the likelihood of bias, allocation concealment selection is performed using unique codes in each of the treatments, so that the researcher and volunteers participating in the study and statistical analysis of the drug or the placebo of vaginal gels are completely unaware. Vaginal gel tubes are filled by the pharmacist.The vaginal gel of the oak Gall and the placebo are numbered and packaged in sequences in the similar envelopes, respectively. The drug envelopes are then given to control and intervention groups. Group allocation is random, and using locks of 4 and a one-to-one allocation ratio, individuals are divided into two groups of 50 intervention and control. To hide the allocation and prevent bias, the numbers of the intervention and control groups are placed in closed envelopes then are delivered to the eligible participants by the secretary of the menopausal clinic. Each person is given an envelope containing 1 60-gram tube of vaginal gel for 4 weeks to use, and the drug code is included. The person's checklist is recorded, Blinding description: This study is a triple-blind clinical trial study(researcher, participant, statistical analyst) and coding of vaginal gel tubes is done by a pharmacist. 3 Condition 1: Loosening of the pelvic floor muscles. Condition 2: Sexual Dysfunction. Intervention 1: Intervention group: Vaginal gel with a concentration of 2.5% made in the laboratory of Ahvaz School of Pharmacy is given to postmenopausal women daily for 12 weeks. Intervention 2: Control group: The control group includes 50 samples that receive the placebo vaginal gel made in the laboratory of Ahwaz School of Pharmacy for 12 weeks and daily. Yes - There is a plan to make this available What will be shared: Demographic information of individuals and data before and after the intervention is reported without mentioning the name. When: Access started in 1400. To whom: Only researcher in the filed of medical universities Conditions: It can only be used in similar research Where to obtain: Researcher's personal email How to obtain: According to the publication of the article and the registration of the information of the responsible author, the applicant will contact the responsible author to receive the data by academic email and the information will be sent after the approval of the academic email. Comments:
public Sahar Omidianpour
Golestan Blv
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8333 omidianpour.2019@gmail.com Ahvaz University of Medical Sciences scientific Parvaneh Mousavi
Golestan Blv
Ahvaz Iran (Islamic Republic of) 6135539345 +98 61 3373 8333 mousavip2009@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Not menstruating for the past 12 months Sexual Function score less than 26.5 Have literacy Score 28 or less with the prinometer 45 years 65 years Female Chronic diseases Smoking and alcohol consumption Vaginal or cervical infection Getting uterine bleeding or spotting for an unknown reason Taking any type of vaginal medication Breast disease with a specific cause People with grade 3 and 4 pelvic floor muscle relaxation syndrome based on pop-Q Experiencing adverse or stressful events in a woman or her husband F52 Sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Placebo Intervention group: Vaginal gel with a concentration of 2.5% made in the laboratory of Ahvaz School of Pharmacy is given to postmenopausal women daily for 12 weeks. Control group: The control group includes 50 samples that receive the placebo vaginal gel made in the laboratory of Ahwaz School of Pharmacy for 12 weeks and daily. Pelvic floor muscle`s strength. Timepoint: Before the intervention, 4,8and 12 weeks after the start of use of the vaginal gel of the oak Gall. Method of measurement: prinometry. Percentage of people with improved Sexual function. Timepoint: Before the intervention, 4,8and 12 weeks after the start of use of the vaginal gel of the oak Gall. Method of measurement: Sexual Function Index Questionnaire. Sexual Function Score in the Sexual Function index Questionnaire. Timepoint: Before the intervention, 4,8and 12 weeks after the start of use of the vaginal gel of the oak Gall. Method of measurement: Questionnaire FSFI. Ahvaz University of Medical Sciences Approved 2020-05-10 Ethics in Biomedical Research Golestan Blv, Nursing And Midwifery Department Ahvaz Khouzestan Iran (Islamic Republic of)