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IRCT20200925048836N4 IRCT 2023-02-25 Shiraz University of Medical Sciences Evaluation of the effect of Silybum marianum on endometriosis Evaluation of the changes in endometrioma size and AMH levels after treatment with Silybum marianum extract in women with endometriosis 2023-03-11 anticipated 60 Complete https://irct.ir/trial/68594 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method in this study will be the permutation block randomization method, such that "A" represents the subject receiving the intervention (Drug), and "B" represents the subject who receives the placebo. This method is based on 15 blocks in 4 permutations, taking into account all possible quadruple permutations (AABB, ABAB, ABBA, BAAB, BBAA and BABA) and assigning zero to nine (according to a random number table) to each of these permutations, Runs. (AABB Code 0, BABA Code 1, AABB Code 2, BBAA Code 3, BAAB Code 4, and ABBA Code 5 to 9) Then, using a random number table, 15 randomly selected (rows or columns) are selected, and the assigned permutation is written to each number. (The order of placing permutations next to each other is left to right respectively) and how all 60 people will be assigned to two groups A and B, Blinding description: Silybum marianum and pelacebo have been administered in the similar bottles, so patients and researchers were unable to detect which one was Ondansetron or bitter orange peel. Our nurse colleague in this study in hospital delivered formulations to the participants of the study according to Block Balanced Randomization Method by software. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified. 3 Endometriosis. Intervention 1: Intervention group: Silibum Marianum 140 mg twice daily and 30 mg medroxyprogesterone for six months. Intervention 2: Control group: Placebo (starch) tablets twice daily and medroxyprogesterone 30 mg for 6 months. Yes - There is a plan to make this available What will be shared: Statistical Results When: 6 month after the project completion To whom: By obtaining a license from the ethics committee and for scientific and research use in coordination with the main researchers Conditions: The data is for use in this design only. If necessary, after obtaining the necessary permits from the ethics committee Where to obtain: To researchers responsible for responding to this plan How to obtain: Written request Coordinated by the ethics committee 2 months Comments:
public Dr.Elham Askari
Zand St., Faqihi Hospital, Office of Obstetrics and Gynecology
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3233 2365 elliaskary_md@yahoo.com Shiraz University of Medical Sciences scientific Elham Askary
Zand St., Faqihi Hospital, Office of Obstetrics and Gynecology
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3233 2365 elliaskary_md@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Endometriosis recorded by transvaginal ultrasound or transrectal ultrasound by a gynecologist No history of endometriosis surgery Without any chronic inflammatory disease and chronic medical conditions such as cancer, diabetes, cardiovascular disease and rheumatic disease Age less than 45 years old The patient is without surgical indication 18 years 45 years Female Breast Cancer probability of side effects such as severe nausea, vomiting, diarrhea or gastrointestinal symptoms Previous endometriosis surgery Cervical or ovarian cancer Uterine fibroid N80.1 Endometriosis of ovary Treatment - Drugs Placebo Intervention group: Silibum Marianum 140 mg twice daily and 30 mg medroxyprogesterone for six months. Control group: Placebo (starch) tablets twice daily and medroxyprogesterone 30 mg for 6 months. AMH level. Timepoint: Six months after starting the medication. Method of measurement: Hormone kits (Diazist). Endometrioma size. Timepoint: At the beginning of the study and 6 months later. Method of measurement: Transvaginal or transrectal ultrasonography. Shiraz University of Medical Sciences Approved 2023-02-05 Shiraz University of Medical Sciences Building of Shiraz University of Medical Sciences, Zand Ave Shiraz Fars Iran (Islamic Republic of)