Investigating the effect of rose vaginal gel on postmenopausal women’s menopausal symptoms: A randomized, double-blind, controlled clinical trial

The effect of rose vaginal gel on menopausal symptoms of postmenopausal women

This study is a randomized clinical trial with a control group and a parallel design. This double-blinded, randomized study will be conducted on 44 eligible women. A random block is used for randomization and the participants are assigned to two intervention and control groups.

This study, which will be conducted in Kermanshah clinics, is double-blinded. Before starting the study, the menopause questionnaire will be provided to the participants and then they will be taught how to use the ointment.

Inclusion criteria: At least one year has passed since the last menstrual period or having a hormone test with an FSH level greater than 40 international units; Obtaining a score of 5 or more from the MRS questionnaire; Age between 45 and 65 years; Being married; Absence or history of uterine and breast cancer Exclusion criteria: Having uterine bleeding or spotting with an unknown cause; Vaginal infection requires treatment; Abnormalities of the genital system; Under sex hormone therapy within 8 weeks before the study; Use of vaginal drugs or any lubricants at least 15 days before the study; Smoking (alcohol, cigarettes, hookah); Body mass index more than 30 kg/m2; Cholestatic liver disorders, severe kidney failure, acute thromboembolism and high blood pressure

For the intervention group, each participant will be given a 50-gram tube with an applicator, instructions for use, and a side effects registration form for use for 12 weeks. The method of consumption is every night for two weeks and the next ten weeks in the form of one gram twice a week. The control group will receive a placebo.

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In this study, the block randomization method will be used using blocks of 4. A third person who does not have any involvement in the process of taking patients and evaluating patients. Using the site: https://www.sealedenvelope.com will create a random sequence and based on the sample size, 15 blocks of 4 will be created. Each patient will be given a unique code that can be created on this site.

In order to hide the allocation of drug and placebo tubes, both groups, which are in the same package, are coded by the pharmacist with 2 codes. Code A for rose flower and code B for placebo, including people in the study and delivering the envelopes will be done by the researcher. Neither the patient nor the person evaluating the patient will know what medication has been received. Medicines are sealed and an arrangement will be adopted that only people of one group will visit on that day during re-evaluation. This will be planned by a statistical consultant who knows the codes.

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