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IRCT20230318057754N1 IRCT 2024-01-24 Shahid Beheshti University of Medical Sciences Comparative study of the combined effect of black cohosh and misoprostol on the rippening cervix prior to hysteroscopy in postmenopausal women Comparative study of the combined effect of black cohosh and misoprostol on the rippening cervix prior to hysteroscopy in postmenopausal women 2024-03-10 anticipated 66 Complete https://irct.ir/trial/69409 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B. 2-3 Menopause. Intervention 1: Intervention group: 6-8 hours before the operation, in addition to 200 micrograms of misoprostol (Samisaz Pharmaceutical Company), they will receive 80 mg of black cohosh (Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences). Medicines are used vaginally and a single dose is used. Intervention 2: Control group: take 200 micrograms of misoprostol (Samisaz Pharmaceutical Company) 6-8 hours before surgery. Medicines are used vaginally and one dose is used. Yes - There is a plan to make this available What will be shared: All individual data of the participants in this study will be shared after unidentifiable individuals When: The access period will start from 2022to 2023 To whom: Data will be available to researchers working in the university. Conditions: Just for performing research Where to obtain: Refer to the responsible person for accessing the data How to obtain: The data will be available one month after the responsible person's approval Comments:
public Athena Behforouz
Tehran Province, Tajrish، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 dean.medicalschool@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Athena Behforouz
Tehran Province, Tajrish، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 dean.medicalschool@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Post-menopausal women who, according to the definition, have passed their last period for more than 1 year and are candidates for elective hysteroscopy due to post-menopausal bleeding (polyp, myoma or endometrial thickening). no limit no limit Female E35 Disorders of endocrine glands in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: 6-8 hours before the operation, in addition to 200 micrograms of misoprostol (Samisaz Pharmaceutical Company), they will receive 80 mg of black cohosh (Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences). Medicines are used vaginally and a single dose is used. Control group: take 200 micrograms of misoprostol (Samisaz Pharmaceutical Company) 6-8 hours before surgery. Medicines are used vaginally and one dose is used. Cervix rippening. Timepoint: Before and after surgery. Method of measurement: Patient response based on Visual Analogue Scale (VAS) score. Complications of hysteroscopy including bleeding and pain. Timepoint: Before and after surgery. Method of measurement: Patient response based on Visual Analogue Scale (VAS) score. Shahid Beheshti University of Medical Sciences Approved 2023-12-26 Ethics committee of shahid beheshti University of Medical Sciences Tehran Province, Tajrish، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave Tehran Tehran Iran (Islamic Republic of)