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IRCT20180923041099N1 IRCT 2019-02-24 Gorgan University of Medical Sciences Effect of Alcea in treatment of vaginal atrophy. Investigation of the effect of Alcea vaginal suppository on the treatment of vaginal atrophy in postmenopausal women. 2019-03-02 anticipated 60 Complete https://irct.ir/trial/34107 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: To both groups, life style modification of Traditional Persian Medicine, are offered, Randomization description: Randomization method: Permuted block randomization; Random unit: Individual; Randomization Tool: block; How to create a random sequence: From the four blocks, we select one, by accident (Roll of a die), and according to the order, assign the samples to two groups A and B, and so continue until the end we give. Allocation concealment:This is a double-blind, placebo-controlled study. As the patient and researcher of the project are not aware of the content of the treatment. In both groups, vaginal suppositories are identical in terms of shape, odor, size, and color, Blinding description: The study is conducted randomly, double-blind, and controlled by placebo. Participants are randomly selected and divided into two groups of intervention and control. The intervention group, the Alcea vaginal suppository, and the control group, are given placebo suppositories that are uniform in shape, odor, size and color, so the participants are unaware of the type of treatment. The researcher will provide Alcea suppository and placebo to clinical care providers, and she distributes them according to the patient's condition. Therefore, only clinical care providers are aware of the type of treatment, and during the treatment, the investigator and the assessor of the outcome, are unaware. 3 Vaginal atrophy. Intervention 1: Intervention group: Alcea vaginal suppository(5%) every night for 2 weeks, followed by every other night administration for a further 6 weeks. Duration of treatment is 8 weeks. All stages of construction of suppositories are carried out by the professor of pharmacy at the Traditional Medicine Laboratory of Mashhad. At first, the Alcea angulata dried with Voucher number (FUMH-E 1009) from the Faculty of Agriculture, Ferdowsi University of Mashhad, was prepared and extracted by soaking. Then, 5% of the extract was added to the suppository base (PEG). Standardization of suppositories takes place in Folin–Ciocalteu method in 3 steps. Intervention 2: Control group:placebo, vaginal suppository every night for 2 weeks, followed by every other night administration for a further 6 weeks. Duration of use is 8 weeks.The placebo suppository containing the suppository base (PEG) made by the professor of pharmacy at the Traditional Medicine Laboratory of Mashhad. These suppositories are very similar to the Alcea suppositories in terms of shape, size, color and smell. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of ethical principles and assuring patients that their specifications are not disclosed
public Alieh Kiani Talaei
Golestan University of Medical Sciences; Shastkola Road
Gorgan Iran (Islamic Republic of) 9178955448 +98 51 3869 5550 kianita941@mums.ac.ir Gorgan University of Medical Sciences scientific Marzieh Gharaaty
Golestan University of Medical Sciences; Shastkola Road
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 1653 Gharaaty1387@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Married women, and have sexual activity; Age between 40-65 years; Complaint of vaginal dryness; Amenorrhea for at least 12 months, or laboratory confirmation of menopause(FSH>40); Amenorrhea after surgery and Bilateral Oophorectomy; 40 years 65 years Female Endometrial cancer or breast cancer or suspicion of it; Vaginal bleeding with unknown causes; Vaginal infection; History of sensitivity to the Alcea; Chronic diseases; The history of consumption of hormonal products containing estrogen and progesterone in the last month; The history of vaginal use of stimulants that can cause chronic vaginal itching (scents, moisturizers, soaps) in the last month; N95.2 Postmenopausal atrophic vaginitis Treatment - Drugs Placebo Intervention group: Alcea vaginal suppository(5%) every night for 2 weeks, followed by every other night administration for a further 6 weeks. Duration of treatment is 8 weeks. All stages of construction of suppositories are carried out by the professor of pharmacy at the Traditional Medicine Laboratory of Mashhad. At first, the Alcea angulata dried with Voucher number (FUMH-E 1009) from the Faculty of Agriculture, Ferdowsi University of Mashhad, was prepared and extracted by soaking. Then, 5% of the extract was added to the suppository base (PEG). Standardization of suppositories takes place in Folin–Ciocalteu method in 3 steps. Control group:placebo, vaginal suppository every night for 2 weeks, followed by every other night administration for a further 6 weeks. Duration of use is 8 weeks.The placebo suppository containing the suppository base (PEG) made by the professor of pharmacy at the Traditional Medicine Laboratory of Mashhad. These suppositories are very similar to the Alcea suppositories in terms of shape, size, color and smell. Symptoms of vaginal atrophy. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: The most bothersome symptom of vaginal mucosa with Visual Analogue Scale. Vaginal superficial cells. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: vaginal maturation index. Vaginal PH. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: PH meter. Sexual satisfaction. Timepoint: Before intervention, Eight weeks after intervention. Method of measurement: Standard Questionnaire for Assessment of Female Sexual function (FSFI). Gorgan University of Medical Sciences Approved 2019-02-04 Ethics committee of Golestan University of Medical Sciences Golestan University of Medical Sciences; Shastkola Road. Gorgan Golestan Iran (Islamic Republic of)