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IRCT20160101025791N3 IRCT 2019-03-04 Kermanshah University of Medical Sciences Treatments of Idiopathic Granulomatous Mastitis Comparison of three types of treatments in patients with Idiopathic Granulomatous Mastitis 2018-10-28 anticipated 150 Complete https://irct.ir/trial/34829 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We is located four-piece papers (to the total number of patients) in a small box. On each paper, the number of each group has been written. The patient is asked to remove randomly one of the papers and read the number. The patient is not given any information about the type of treatments and the groups, Blinding description: Participant and Clinical Clinician (Physician) are kept blind. The study is double-blind. Participants are placed in each group respectively. The investigator (physician assistant) collects information. Researcher prepares the paper. The doctor evaluates the outcome. 3 Idiopathic Granulomatous Mastitis. Intervention 1: Group 1: Some doctors believe that the disease does not need to be treated at a warm, red, and massive stage, but if it leads to an abscess, it will empty the abscess and give antibiotics. This is the best remedy. Intervention 2: Group 2: Because of the autoimmune disease, another group of doctors believes that the treatment of this disease is using corticosteroids such as prednisolone. In this group, the daily dose of 5mg / m2 decreases from dose to drug discontinuation. Intervention 3: Group 3: Many patients can't continue prednisolone, they use prednisolone + immunosuppressants (such as methotrexate) in these patients. In this group, prednisone is given high doses (4 mg / m2) twice a week orally and rescue folic acid on days when the methotrexate tablet is not used for 18 months. Yes - There is a plan to make this available What will be shared: Undecided - It is not yet known if there will be a plan to make this available When: Undecided - It is not yet known if there will be a plan to make this available To whom: Undecided - It is not yet known if there will be a plan to make this available Conditions: Undecided - It is not yet known if there will be a plan to make this available Where to obtain: Undecided - It is not yet known if there will be a plan to make this available How to obtain: Undecided - It is not yet known if there will be a plan to make this available Comments:
public Mazaher Ramezani
Nursing Blvd, Imam Reza Hospital, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714415333 +98 83 3427 6300 Mazaher_ramezani@yahoo.com Kermanshah University of Medical Sciences scientific Mazaher Ramezani
Imam Reza Hospital, Nursing Blvd, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714415333 +98 83 3427 6300 mazaher_ramezani@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Female patients Patients without systematic diseases no limit no limit Female Pregnant women Women with a history of breast cancer in the family L92 Granulomatous disorders of skin and subcutaneous tissue Treatment - Drugs Treatment - Drugs Treatment - Drugs Group 1: Some doctors believe that the disease does not need to be treated at a warm, red, and massive stage, but if it leads to an abscess, it will empty the abscess and give antibiotics. This is the best remedy. Group 2: Because of the autoimmune disease, another group of doctors believes that the treatment of this disease is using corticosteroids such as prednisolone. In this group, the daily dose of 5mg / m2 decreases from dose to drug discontinuation. Group 3: Many patients can't continue prednisolone, they use prednisolone + immunosuppressants (such as methotrexate) in these patients. In this group, prednisone is given high doses (4 mg / m2) twice a week orally and rescue folic acid on days when the methotrexate tablet is not used for 18 months. Response to treatment. Timepoint: Before and after 6 months of intervention. Method of measurement: ELISA kit. White blood cell. Timepoint: Before and after 6 months of intervention. Method of measurement: LeukoChek test kit. Kermanshah University of Medical Sciences Approved 2018-10-10 Ethics Committee of Kermanshah University of Medical Sciences Vice – Chancellery of Research & Technology Affairs, building No.2, Shahid Beheshti Blvd., Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)