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IRCT20120922010901N10 IRCT 2023-05-08 Vice chancellor for Research,Tabriz University Of Medical Sciences The effect of melatonin on endometrial histology in patients with disordered simple hyperplasia. The effect of melatonin and megestrol acetate compared to megestrol acetate alone on endometrial histology in patients with endometrial proliferative disorders: a double blind randomized clinical trial 2023-02-20 anticipated 40 Complete https://irct.ir/trial/68200 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple random allocation method will be used. In this method, a list of numbers from 1 to 40 will be prepared. In this list, numbers are randomly divided. Depending on the time of the patient's visit, one of these numbers will be assigned to the patient, and based on the created list and being even or odds, the patients will be assigned to the intervention and the control groups. The intervention group will be even numbers and the control group will be odd numbers. Then, the sealed envelope method will be used for concealment. In this way, each number will be written on a card and then placed inside the envelopes. We will glue the lids of the envelopes and put them in the boxes. for Participants in order of entering, one of the envelopes will be opened and the assigned group to that participant will be determined, Blinding description: The drugs are blindly coded while they are manufactured uniform and the participant and clinical caregiver will be unaware of their content.In addition, pathology results without mentioning the type of treatment performed on the patient, with headings A and B will be provided to the analyst to evaluate the consequences.So, these people will be blinded. 3 Endometrial hyperplasia. Intervention 1: Control group:Patients in the control group, will be treated with megestrol acetate at a daily dose of 80mg(Aboureihan Pharmaceuticals Iran]). Patients will be observed for 3 months and endometrial biopsy will be performed in the third month by the same fellow pathologist. Intervention 2: Intervention group: Patients in the intervention group, will be treated with megestrol acetate at a daily dose of 80 mg (Aboureihan Pharmaceuticals [Iran]) + melatonin at a daily dose of 5 mg (Galinus Pharmaceuticals, Iran) before bedtime for three months.Patients will be observed for 3 months and endometrial biopsy will be performed in the third month by the same fellow pathologist. 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 After analyzing the data, a decision will be made.
public Dr. Parvin Mostafa Gharabaghi
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 1553 9161 gharabagh.p@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Parvin Mostafa Gharabaghi
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 1553 9161 gharabagh.p@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age of 38 to 55 years Women with abnormal uterine bleeding and proliferative endometrium with irregular glands Willingness to participate in the study BMI between 18.5 and 29.99 38 years 55 years Female Atypical hyperplasia and endometrial cancer diagnosis History of hormone therapy in the last 3 months Not consent to participate in the study Diabetes History of depression and use of antidepressants Coagulation disorders Hypertension Seizures and the use of antiepileptic drugs Having autoimmune diseases N85.0 Endometrial hyperplasia Treatment - Drugs Treatment - Drugs Control group:Patients in the control group, will be treated with megestrol acetate at a daily dose of 80mg(Aboureihan Pharmaceuticals Iran]). Patients will be observed for 3 months and endometrial biopsy will be performed in the third month by the same fellow pathologist. Intervention group: Patients in the intervention group, will be treated with megestrol acetate at a daily dose of 80 mg (Aboureihan Pharmaceuticals [Iran]) + melatonin at a daily dose of 5 mg (Galinus Pharmaceuticals, Iran) before bedtime for three months.Patients will be observed for 3 months and endometrial biopsy will be performed in the third month by the same fellow pathologist. Histologic types of endometrium. Timepoint: Three months after the first dose of the drug. Method of measurement: Microscopic examination. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2023-04-05 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Nnmber 2 Central Building, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)