]>
IRCT20150905023897N5 IRCT 2020-02-04 Vice chancellor for research Tarbiat Modares University To evaluate the effectiveness of Silymarin (Livergol) on IL-6 levels and size of endometrioma lesions To evaluate the effectiveness of Silymarin (Livergol) on IL-6 levels and size of endometrioma lesions in women with ovarian endometriosis: a randomized, double-blind placebo-controlled trial 2020-02-07 anticipated 60 Complete https://irct.ir/trial/42215 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be done according to a computer-generated list of random number groups prepared using Statistical Analysis System Software Version 9.2 (SAS Institute Inc., Cary, NC, USA). All participants will be randomly allocated to each arm and given the tablets based on a computer-generated randomization list by the investigator, Blinding description: The researcher and patients will be unaware of the treatment and grouping of the study. For this purpose, Levergol tablets and placebo are coded by a research center. The lead researcher treats patients in a double-blind manner based on the drug package code. The code for the drug package is recorded on the personal information form, and the researcher who completes the information form will not be informed of the type of treatment. 2 Endometrioma lesions. Intervention 1: Intervention group: People in the intervention group receive Liverpool 140 mg tablets at the pharmaceutical company twice daily for three months. Intervention 2: Control group: People in the control group used the placebo for exactly three months with exactly the same appearance of the Levergel tablet twice a day for three months. Yes - There is a plan to make this available What will be shared: Information on the main outcome of the study When: 1400 To whom: Academic researchers Conditions: Use for further research in the future Where to obtain: Email Addressing Responsible for Study How to obtain: Submit a request to study and follow up Comments:
public Shahideh Jahanian Sadatmahalleh
Jalal E Al Ahmad
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۱۶ +98 21 2230 6480 Shahideh.jahanian@modares.ac.ir Tarbiat modares University scientific Shahideh Jahanian Sadatmahalleh
Jalal E Al Ahmad
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۱۶ +98 21 2230 6480 shahideh.jahanian@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Iranian married women of reproductive age (15-49) No chronic disease (diabetes, hypertension, liver and kidney disease, previous venous embolism ...) based on medical records Women with a confirmed diagnosis of ovarian endometriosis via transvaginal ultrasonography performed by a single sonologist and CA125 level People are willing to participate in the study 15 years 49 years Female participants suffering from the side effects of silymarin Individuals unwilling to continue participating in the study Failure to comply with treatment protocol Taking specific medications such as anti-depressant, GnRH analogues, systemic glucocorticoids, or other milk thistle products and anti-inflammatory supplements with a specified wash-out period for each one N80.1 Endometriosis of ovary Treatment - Drugs Treatment - Drugs Intervention group: People in the intervention group receive Liverpool 140 mg tablets at the pharmaceutical company twice daily for three months. Control group: People in the control group used the placebo for exactly three months with exactly the same appearance of the Levergel tablet twice a day for three months. Interleukin 6 levels. Timepoint: At the beginning of the study and three months after starting the Livergol pill. Method of measurement: Using the ELISA method in pg / ml. Endometrial lesion volume measurement. Timepoint: At the beginning of the study and three months after starting the Livergol pill. Method of measurement: ultrasound or laparoscopy in millimeters. Sexual function. Timepoint: At the beginning of the study and three months after starting the Livergol pill. Method of measurement: Using the FSFI questionnaire. Quality of Life. Timepoint: At the beginning of the study and three months after starting the Livergol pill. Method of measurement: Using the SF-12 questionnaire. Pelvic pain. Timepoint: At the beginning of the study and three months after starting the Livergol pill. Method of measurement: VAS visual analog scale. Vice chancellor for research Tarbiat Modares University Approved 2019-10-22 Ethics committee of Tarbiat Modares university Jalal AleAhmad-Nasr, Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)