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IRCT20210517051331N1 IRCT 2021-06-07 Ahvaz University of Medical Sciences The effect of Phoenix Dactylifera Spathe vaginal gel on sexual function and Vaginal Atrophy in Menopausal women The effect of Phoenix Dactylifera Spathe vaginal gel on sexual function and Vaginal Atrophy in Menopausal women 2021-06-22 anticipated 110 Complete https://irct.ir/trial/56368 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The grouping of the subjects in each of the intervention and control groups (55 people in each group) is done randomly (random allocation) using a computer random number table and through blocks of 6 and 9 and by a statistician, Blinding description: To conceal allocation, similar and opaque packets are used containing drugs Which are numbered from 1 based on the allocation sequence. 3 Sexual function in menopause; Vaginal atrophy in menopause. Intervention 1: Intervention group: Phoenix Dactylifera Spathe vaginal gel 5% of Phoenix Dactylifera Spathe plant once a day for one month. Phoenix Dactylifera Spathe vaginal gel is made in the Faculty of Pharmacy of Ahwaz Jundishapur University. Intervention 2: Control group: placebo vaginal gel containing gel and preservative will be used once a day for a month. Placebo vaginal gel is made in the Faculty of Pharmacy of Ahwaz Jundishapur University. 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 I will decide on this later
public Rana Rezaei
Unit 5, Parand Apartment, Shahid Adizade Street, Komite Sokht
Shoushtar Iran (Islamic Republic of) 6451854313 +98 61 3624 2356 Rana.rezaei9288@gmail.com Ahvaz University of Medical Sciences scientific Mina Iravani
Faculty of Nursing and Midwifery - University City - Golestan Road - Ahvaz
Ahwaz Iran (Islamic Republic of) 15794-61357 +98 61 3373 8331 iravani-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Being married Be literate No medical condition of the woman or her husband (according to Ms. Menopause) Age range under 65 years More than a year has passed since the last menstrual period Having sex for the past month Have sex at least once a month Existence of symptoms of vaginal atrophy Sexual function score less than 26/55 no limit 65 years Female Any physical or motor disability Training on sexual issues in the last 4 weeks Use of psychiatric drugs, Fluoxetine, Vitamin E, Propranolol and other chemical or herbal medicines that affect menopausal symptoms Smoking and alcohol or drug use N95 Menopausal and other perimenopausal disorders Treatment - Drugs Placebo Intervention group: Phoenix Dactylifera Spathe vaginal gel 5% of Phoenix Dactylifera Spathe plant once a day for one month. Phoenix Dactylifera Spathe vaginal gel is made in the Faculty of Pharmacy of Ahwaz Jundishapur University. Control group: placebo vaginal gel containing gel and preservative will be used once a day for a month. Placebo vaginal gel is made in the Faculty of Pharmacy of Ahwaz Jundishapur University. Vaginal atrophy- Maturity index of vaginal mucosa cells. Timepoint: Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel. Method of measurement: To examine the maturity index of vaginal mucosal cells, using a sterile cotton swab, a sample of vaginal secretions and posterior fornix is taken and spread on the slide. The slide is then fixed with a fixator and placed in envelopes on which the patient's profile is written. Then, the slides prepared from the patients are sent to the pathology laboratory of Ahvaz Jundishapur University of Medical Sciences and the samples are examined for vaginal atrophy. Mental symptoms of vaginal atrophy. Timepoint: Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel. Method of measurement: Mental symptoms of vaginal atrophy will be assessed according to a 4-point self-assessment scale of a combined score including: burning, itching, vaginal dryness and dyspareunia, so that the severity of each symptom is determined by the patient and then a score according to criterion 4 A degree (0 = absence, 1 = mild = 2 moderate and 3 = severe) was given to them by the researcher and by adding the numbers related to each of the symptoms, the combined score will be calculated. Vaginal PH. Timepoint: Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel. Method of measurement: During vaginal examination with a speculum, a paper strip of pH meter is contacted to the vaginal wall with a pair of pliers and held for one minute. Clinical signs of Vaginal atrophy. Timepoint: Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel. Method of measurement: Clinical signs of atrophy are assessed by completing a descriptive evaluation table of vaginal mucosa, and if there are at least 2 symptoms of the table (vaginal folds, color, petechiae, elasticity and vaginal dryness) vaginal atrophy is diagnosed. Sexual Function. Timepoint: Before the study and 30 days after taking Phoenix Dactylifera Spathe vaginal gel. Method of measurement: Using a questionnaire FSFI. Ahvaz University of Medical Sciences Approved 2021-05-09 Ethics Committee of Ahwaz Jundishapur University of Medical Sciences Unit 5, Parand Apartment, Shahid Afzalan Street, Komite Sokht Shoushtar Khouzestan Iran (Islamic Republic of)