Evaluation of the changes in endometrioma size and AMH levels after treatment with Silybum marianum extract in women with endometriosis

Evaluation of the changes in endometrioma size and Anti-Müllerian Hormone levels after treatment with Silybum marianum extract in women with endometriosis

Clinical trial with control group; with parallel groups; double blinded; randomized; design of 60 patients

Patient will be assigned into 2 groups with block randomization method, 30 patients will be treated by Silybum marianum and 30 patients will be received bitter pelacebo. Drugs are named to A and B and have been administered in the similar bottle.All patients are visited every 3 months to assess compliance with treatment. The blood level of AMH is evaluated at the beginning of the study and 6 months after the treatment in Amjadi laboratory complex. At the beginning of the study, 6 months later, to evaluate the presence and size of endometrioma, transvaginal or transrectal ultrasound is performed by an expert gynecologist and university faculty member.

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. Exclusion criteria: breast cancer; if the patient has a condition that worsens with estrogen exposure, she should not use sage extract. Uterine fibroids and possible side effects such as severe nausea, vomiting, diarrhea or gastrointestinal symptoms; previous endometriosis surgery; cervical or ovarian cancer.

60 subjects will be assigned into 2 groups with block randomization method, 30 patients will be treated by Silybum marianum and 30 patients will be received bitter pelacebo

Endometrioma size and AMH level

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.

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.

Statistical Results

6 month after the project completion

By obtaining a license from the ethics committee and for scientific and research use in coordination with the main researchers

The data is for use in this design only. If necessary, after obtaining the necessary permits from the ethics committee

To researchers responsible for responding to this plan

Written request Coordinated by the ethics committee 2 months