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IRCT20211013052757N1 IRCT 2022-02-11 Esfahan University of Medical Sciences The effect of four flower herbal vaginal gel and auricular therapy on atrophic vaginitis The effect of four flowers herbal vaginal gel and auriculotherapy in comparison with placebo on atrophic vaginitis in women referred to selected medical centers affiliated to Isfahan University of Medical Sciences in 2021 2021-12-22 anticipated 90 Complete https://irct.ir/trial/60596 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 90 patients were eligible to enter the study randomly, using the random number table available at the site, in two age groups under 60 years and over 60 years, in three groups of uriculotherapy, herbal gel and placebo (A, B, C) Will be divided. Because there is no possibility of blinding the participant and the researcher in the oriculotherapy group, group C will be known as the oriculotherapy group from the very beginning, Blinding description: Interventions in patients consuming vaginal gel and placebo are in the form of three blinds, so that the patient and the researcher are not aware that the patient is taking the drug or placebo.However, in the uriculotherapy group, due to the impossibility, blindness was not performed. 2-3 Volvovaginal atrophy. Intervention 1: First intervention group: In the herbal vaginal gel group, in the first session after completing the forms, 4 tubes of vaginal gel in 30 gram tubes are delivered to the patient for consumption for four weeks. How to take the drug in the first 4 weeks: Every night before going to bed, use a 5-gram applicator inside the vagina and do not get up for a few hours to absorb the drug. And Women's Sexual Performance Index Questionnaire and Quality of Life Assessment Questionnaire will be completed for each.Then another 2 tubes are delivered to patients for consumption in the next 4 weeks. How to take the medicine in the second 4 weeks: One night before going to bed, use a 5 g applicator inside the vagina and do not get up for a few hours to absorb the medicine. At the end of 8 weeks of intervention, the forms will be completed again. Intervention 2: Second intervention group: In the case of the uriculotherapy group, the patient visits for uricotherapy once a week from the beginning of the study.At each visit, the points related to vaginal atrophy in the ear were identified first and then placed on the points related to Seyed Vakaria. The patient is instructed to press each side for 1 minute every hour (except when the patient is asleep). There is no problem in taking a shower while the patient is sick.Forms and questionnaires in the uriculotherapy group will be completed at the beginning of the intervention, the end of the fourth week and the end of the eighth week. Intervention 3: Control group: In the control group, in the first session after completing the forms, 4 tubes of placebo in 30 gram tubes in a completely uniform shape are delivered to the patient for consumption for four weeks. How to take the drug in the first 4 weeks: Every night before going to bed, use a 5-gram applicator inside the vagina and do not get up for a few hours to absorb the drug. And Women's Sexual Performance Index Questionnaire and Quality of Life Assessment Questionnaire will be completed for each.Then another 2 tubes are delivered to patients for consumption in the next 4 weeks. How to take the medicine in the second 4 weeks: One night before going to bed, use a 5 g applicator inside the vagina and do not get up for a few hours to absorb the medicine. At the end of 8 weeks of intervention, the forms will be completed again. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Elahe Naderiafshar
Department of Iranian Medicine, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib St.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 8155 e.naderiafshar@resident.mui.ac.ir Esfahan University of Medical Sciences scientific Elahe Naderiafshar
Department of Iranian Medicine, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib St.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 8155 e.naderiafshar@resident.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age: 45 to 65 years old 12 months have passed since menopause Symptoms of vaginal atrophy Patient consent to participate in the project Being married Natural Pap smear in the past year 45 years 65 years Female Breast or uterine cancer Abnormal vaginal bleeding Vaginal device abnormalities Taking oral hormonal medication 8 weeks before treatment Use of topical hormonal creams or topical lubricants in the last month N95.2 Postmenopausal atrophic vaginitis Behavior Behavior Behavior First intervention group: In the herbal vaginal gel group, in the first session after completing the forms, 4 tubes of vaginal gel in 30 gram tubes are delivered to the patient for consumption for four weeks. How to take the drug in the first 4 weeks: Every night before going to bed, use a 5-gram applicator inside the vagina and do not get up for a few hours to absorb the drug. And Women's Sexual Performance Index Questionnaire and Quality of Life Assessment Questionnaire will be completed for each.Then another 2 tubes are delivered to patients for consumption in the next 4 weeks. How to take the medicine in the second 4 weeks: One night before going to bed, use a 5 g applicator inside the vagina and do not get up for a few hours to absorb the medicine. At the end of 8 weeks of intervention, the forms will be completed again. Second intervention group: In the case of the uriculotherapy group, the patient visits for uricotherapy once a week from the beginning of the study.At each visit, the points related to vaginal atrophy in the ear were identified first and then placed on the points related to Seyed Vakaria. The patient is instructed to press each side for 1 minute every hour (except when the patient is asleep). There is no problem in taking a shower while the patient is sick.Forms and questionnaires in the uriculotherapy group will be completed at the beginning of the intervention, the end of the fourth week and the end of the eighth week. Control group: In the control group, in the first session after completing the forms, 4 tubes of placebo in 30 gram tubes in a completely uniform shape are delivered to the patient for consumption for four weeks. How to take the drug in the first 4 weeks: Every night before going to bed, use a 5-gram applicator inside the vagina and do not get up for a few hours to absorb the drug. And Women's Sexual Performance Index Questionnaire and Quality of Life Assessment Questionnaire will be completed for each.Then another 2 tubes are delivered to patients for consumption in the next 4 weeks. How to take the medicine in the second 4 weeks: One night before going to bed, use a 5 g applicator inside the vagina and do not get up for a few hours to absorb the medicine. At the end of 8 weeks of intervention, the forms will be completed again. Volvaginal Atrophy Mental Symptoms. Timepoint: Completion of Volvaginal Atrophy Mental Symptoms Questionnaire before intervention, end of week 4 and end of week 8 after intervention. Method of measurement: Volvaginal Atrophy Mental Symptoms Questionnaire. Women's sexual function index. Timepoint: Completion of women's sexual function index questionnaire before the intervention, end of week 4 and end of week 8 after the intervention. Method of measurement: Women's sexual function index questionnaire. Quality of life for postmenopausal women. Timepoint: Completion of quality of life evaluation questionnaire for postmenopausal women before the intervention, end of week 4 and end of week 8 after the intervention. Method of measurement: Quality of life evaluation questionnaire for postmenopausal women. Esfahan University of Medical Sciences Approved 2021-12-24 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences and Health Services, Hezar Jerib St. Esfahan Isfehan Iran (Islamic Republic of)