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IRCT20220201053908N1 IRCT 2022-02-23 Semnan University of Medical Sciences Comparing the effects of Berberine, Curcumine and gonadotropin-releasing hormone agonist (GnRH) on uterine leiomyoma volume Comparing the effects of Berberine, Curcumine and gonadotropin-releasing hormone agonist (GnRH) on uterine leiomyoma volume , a controlled, randomized clinical trials 2022-03-06 anticipated 102 Complete https://irct.ir/trial/61650 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment will be done using the randomized permutation block method. The three study groups are named A, B and C and are written randomly in triplicate blocks and the order list of groups is provided to us. This will be done by a statistical study consultant who is not present at the clinical trial. 3 Uterine myoma. Intervention 1: Intervention group: The first group treated with curcumin, each tablet contains 450mg of turmeric rhizome powder and 50mg of turmeric extract, which is standardized based on 5.47mg of curcumin. Once a day, one tablet, made by Dineh Company. Intervention 2: Intervention group: The second group treated with berberine capsule, 1000mg pure berberine extract extracted from barberry plant. One capsule twice a day, Omid Parsina Damavand Company. Intervention 3: Control group: The third group treated with leuprorelin acetate in the form of an ampoule containing 3.75 mg of leuprorelin acetate by subcutaneous or intradermal injection of one dose per month, made by Varian Pharmed Company. 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 There is no more information
public Elham saffarieh
Amir Al-Momenin Hospital, Shahid Mostafa Khomeini Boulevard, Imam Hossein Square
Semnan Iran (Islamic Republic of) 3519734731 +98 23 3346 0055 eli_saffarieh@yahoo.com Semnan University of Medical Sciences scientific Elham saffarieh
Amir Al-Momenin Hospital, Shahid Mostafa Khomeini Boulevard, Imam Hossein Square
Semnan Iran (Islamic Republic of) 3519734731 +98 23 3346 0055 eli_saffarieh@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Non-menopausal women between the ages of 18 and 45, who have a myoma larger than 5 cm that have abnormal uterine bleeding, pelvic pain, dysmenorrhea, and a compressive effect. Women with myomas larger than or equal to 5 cm who have other myomas (s) less than 2 cm in size 18 years 45 years Female Women with extra myoma (s) greater than or equal to 2 cm Women with uterine myoma who have been treated with any type of estrogen or progesterone in less than a month and hormonal implants in the last 3 months Women with a history of major medical illness and / or previous drug or surgical treatment of uterine leiomyomas All women with myomas 2-5 cm in size were excluded from the study Patients receiving antihypertensive drugs, beta-blockers and calcium channel blockers, and ACE inhibitors were excluded from the study due to possible drug interactions Patients who develop side effects during the study will be excluded from the study Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The first group treated with curcumin, each tablet contains 450mg of turmeric rhizome powder and 50mg of turmeric extract, which is standardized based on 5.47mg of curcumin. Once a day, one tablet, made by Dineh Company Intervention group: The second group treated with berberine capsule, 1000mg pure berberine extract extracted from barberry plant. One capsule twice a day, Omid Parsina Damavand Company Control group: The third group treated with leuprorelin acetate in the form of an ampoule containing 3.75 mg of leuprorelin acetate by subcutaneous or intradermal injection of one dose per month, made by Varian Pharmed Company Uterine myoma size. Timepoint: At the beginning of the study and 6 and 12 weeks after starting treatment. Method of measurement: Vaginal ultrasound machine. LH hormon. Timepoint: At the beginning of the study and 12 weeks after treatment. Method of measurement: RIA laboratory method. FSH hormon. Timepoint: At the beginning of the study and 12 weeks after treatment. Method of measurement: RIA laboratory method. Estradiol hormon. Timepoint: At the beginning of the study and 12 weeks after treatment. Method of measurement: RIA laboratory method. Semnan University of Medical Sciences Approved 2022-01-24 Ethics committee of Semnan University of Medical Siences Amir Al-Momenin Hospital, Mostafa Khomeini St., Imam Hossein Square Semnan Semnan Iran (Islamic Republic of)