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IRCT20220116053735N1 IRCT 2022-06-19 Kashan University of Medical Sciences The effect of melatonin supplementation with progesterone on the improvement and level of inflammatory factors in patients with endometrial hyperplasia The effect of melatonin supplementation with progesterone on the improvement and level of inflammatory factors in patients with endometrial hyperplasia 2022-03-20 anticipated 40 Complete https://irct.ir/trial/62216 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in the form of a table of random numbers. Random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and has become a table. To use a table of random numbers, the table is first pre-set for reading numbers (for example, up, down, left, or right), the second assumption is to consider numbers for different groups (for example, even numbers for intervention A and Individual numbers for intervention B) Then the researcher touches one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups, Blinding description: Due to the fact that in the present study, placebo was used to eliminate any bias in the effectiveness of drugs, participants, researchers and clinical caregivers were blinded. Each participant is assigned a code based on the type of drug. N/A Hyperplasia. Intervention 1: Intervention group: Two medroxyprogesterone 5 mg tablets (manufactured by Caspian) and two 10 mg melatonin tablets (manufactured by Galenus) are given every night from the fifteenth day of the cycle for two weeks to three one-month periods. Intervention 2: Control group: Two medroxyprogesterone 5 mg tablets and two placebo tablets are prescribed every night from the fifteenth day of the cycle for two weeks to three one-month periods. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: Access period starts 6 months after the results are published To whom: Researchers working in academic institutions Conditions: Get permission from the project manager Where to obtain: By email How to obtain: Email request Comments:
public Neda Aslany
Isfahan
Isfahan Iran (Islamic Republic of) 8565215532 +98 916 290 7375 aslany-n@Kaums.ac.ir Kashan University of Medical Sciences scientific Neda Aslany
Isfahan
Isfahan Iran (Islamic Republic of) 8565213265 +98 916 290 7375 aslany-n@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with endometrial atypical hyperplasia, without a history of treatment, referred to the clinic of Beheshti Hospital in Kashan, no limit no limit Female Pregnancy E32.0 Persistent hyperplasia of thymus Treatment - Drugs Placebo Intervention group: Two medroxyprogesterone 5 mg tablets (manufactured by Caspian) and two 10 mg melatonin tablets (manufactured by Galenus) are given every night from the fifteenth day of the cycle for two weeks to three one-month periods. Control group: Two medroxyprogesterone 5 mg tablets and two placebo tablets are prescribed every night from the fifteenth day of the cycle for two weeks to three one-month periods. One consequence of the study is the lack of observation of hyperplastic lesions in pathology examination and report of secondary pathology. Another consequence is an increase in the levels of the above inflammatory factors in re-testing by ELISA at the end of the fourth month of treatment. Timepoint: monthly. Method of measurement: In this study, interviews and observations and researcher-made checklists were used. Kashan University of Medical Sciences Approved 2021-12-05 Kashan University of Medical Sciences Kashan Kashan Isfehan Iran (Islamic Republic of)