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IRCT20120922010901N9 IRCT 2022-01-16 Vice chancellor for Research,Tabriz University Of Medical Sciences The effect of herbal mixture extract on endometrial histology in patients with disordered simple hyperplasia. The effect of herbal mixture extract on endometrial histology in patients with disordered proliferative endometrium and simple hyperplasia. 2022-01-10 anticipated 80 Complete https://irct.ir/trial/60967 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, we will do the randomization using the program (www.graphpad.com). 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: Patients are then randomly divided into two groups (A and B). Patients in the control group will receive placebo with megestrol. Then the 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. 2 malignant neoplasm of female genital organs. Intervention 1: Intervention group: Intervention group will consume Megestrol Acetate (40 mg) daily along with a medicinal herb mixture (500 mg) daily for three months. Intervention 2: Control group:Patients in the control group will receive Megestrol Acetate (40 mg) daily with placebo(which is similar in shape, size and color to herbal medicine) (500 mg) daily for three months. 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) Women with abnormal uterine bleeding and proliferative endometrium with irregular glands Willingness to participate in the study Lack of sensitivity to the plants used in the study 18 years no limit Female Thromboembolism Severe liver dysfunction High blood pressure C54.1 malignant neoplasm of female genital organs Treatment - Drugs Treatment - Drugs Intervention group: Intervention group will consume Megestrol Acetate (40 mg) daily along with a medicinal herb mixture (500 mg) daily for three months Control group:Patients in the control group will receive Megestrol Acetate (40 mg) daily with placebo(which is similar in shape, size and color to herbal medicine) (500 mg) daily for three months. Endometrial histology. Timepoint: Before intervention, three months after intervention. Method of measurement: Endometrial biopsy. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2021-11-29 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)