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IRCT20240207060932N1 IRCT 2024-03-03 Ahvaz University of Medical Sciences The effect of Persicaria hydropiper vaginal cream based on coconut oil and sesame oil on vaginal atrophy and sexual function Comparison of the effects of Persicaria hydropiper vaginal cream based on coconut oil and sesame oil with conjugated estrogen vaginal cream and placebo on vaginal atrophy and sexual function of postmenopausal women. 2024-04-08 anticipated 111 Complete https://irct.ir/trial/75450 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning the intervention to people is randomly and by the method of randomized permutation blocks with random block sizes of 6, 9 and 12 (using the table related to random permutations). The randomization list is prepared by a statistician. The intervention used in this research is allocated according to the randomized list by a person outside the study who is not aware of the research objectives and according to the corresponding codes in the sealed envelopes. Also, in order to reduce the creation of selection bias, allocation concealment will be done using unique codes allocated to individuals, Blinding description: The researcher and the participants in this research will be completely unaware of the type of treatment (Persicaria hydropiper vaginal cream, conjugated estrogen vaginal cream and placebo vaginal creams). In this way, the tube of vaginal creams will be marked as A, B and C in the same packaging by the pharmacist. 3 Condition 1: Vaginal atrophy in postmenopausal women. Condition 2: sexual function of postmenopausal women. Intervention 1: Intervention group 1 (Standard treatment group): conjugated estrogen vaginal cream 0.625 mg, one mg for 12 weeks (the first two weeks every night and the next ten weeks twice a week), Luqman Pharmaceutical Company. Intervention 2: Intervention group: Persicaria hydropiper vaginal cream based on coconut oil and sesame oil 5%, 0.5 g for 12 weeks (the first two weeks every night and the next ten weeks twice a week). Intervention 3: Control group: placebo vaginal cream, 0.5 g for 12 weeks (the first two weeks every night and the next ten weeks twice a week). 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 There is no further information
public Mahdieh Ghorbani
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8396 mail.m2018q@gmail.com Ahvaz University of Medical Sciences scientific Mina Iravani
School of Nursing and Midwifery, Jundishapur University of Medical Science, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8396 minairavani2004@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women who have had at least one year since their last menstruation or have an FSH test of more than 40 international units Age range 45-65 years old Being sexually active (the participant and his wife) The ultrasound results of the uterus and ovaries are normal Sexual function index score less than 26.5 Having At least two signs of vaginal atrophy through objective evaluation of the vagina Normality of the results of clinical breast examination 45 years 65 years Female People with or suspected of endometrial and breast cancer and undergoing chemotherapy Abnormal bleeding vaginal infection diabetes cardiovascular disease chronic kidney disease active hepatobiliary disease arthritis mental illness People under hormone therapy in the last 12 weeks People treated with non-hormonal drugs for vaginal atrophy during the last 8 weeks A history of unusual severe drug reactions to medicinal plants taking blood pressure drugs vaginal gels and lubricants thiazide diuretics antihistamines antidepressants lithium digoxin psychoactive drugs danazol benzodiazepines barbiturates N95.2 F52.0 Postmenopausal atrophic vaginitis Hypoactive sexual desire disorder Treatment - Drugs Treatment - Drugs Placebo Intervention group 1 (Standard treatment group): conjugated estrogen vaginal cream 0.625 mg, one mg for 12 weeks (the first two weeks every night and the next ten weeks twice a week), Luqman Pharmaceutical Company Intervention group: Persicaria hydropiper vaginal cream based on coconut oil and sesame oil 5%, 0.5 g for 12 weeks (the first two weeks every night and the next ten weeks twice a week) Control group: placebo vaginal cream, 0.5 g for 12 weeks (the first two weeks every night and the next ten weeks twice a week) Subjective, objective assessment of vaginal atrophy. Timepoint: At the beginning of the research, week 8 and week 12 during treatment, 4 weeks after treatment. Method of measurement: Questionnaire for subjective and objective evaluation of vaginal atrophy and experimental investigation. Maturation percentage of vaginal cells. Timepoint: Before intervention, after intervention. Method of measurement: Based on Meisel's formula. Vaginal acidity. Timepoint: Before intervention, after intervention. Method of measurement: PH gauge. Sexual function. Timepoint: At the beginning of the research, week 8 and week 12 during treatment, 4 weeks after treatment. Method of measurement: Female Sexual Function Index-questionnaire. Ahvaz University of Medical Sciences Approved 2024-01-23 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Associate Professor of Research and Information Technology, Ahvaz Jundishapur University of Medical Sciences, Daneshgahi town, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)