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IRCT2013123015999N1 IRCT 2014-01-27 Vice chancellor for research Isfahan University of Medical Sciences Relapse Rate in an Inflammatory Disease of Breast Treated by Pharmaceutical and Surgical Approaches Comparison of Relapse in Idiopathic Granulomatous Mastitis patients treated either by pharmaceutical or surgical approaches 2012-05-11 anticipated 59 Complete https://irct.ir/trial/15097 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Idiopathic Granulomatous Mastitis. Intervention 1: Intervention : Azithromycin and Prednisolone concomitant application of Azithromycin (250 milligram twice per week) and Prednisolone (40 milligram daily). Afterwards the protocol suggested Prednisolone treatment for eight weeks (40 mg per day) then it was tapered for 6 months. Intervention 2: control:Partial mastectomy.
public Dr. Roya Taleban
Community Medicine Department, School of Medicine, Isfahan University of medical sciences, Hezar Jarib Ave., َAzadi Sq.
Isfahan Iran (Islamic Republic of) +98 31 1792 2542 r.taleban@med.mui.ac.ir Isfahan University of Medical Sciences scientific Dr. Roya Taleban
Community Medicine Department, School of Medicine, Isfahan University of medical sciences, Hezar Jarib Ave., َAzadi Sq.
Isfahan Iran (Islamic Republic of) +98 31 1792 2542 r.taleban@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Women who are well documented Idiopathic Granulomatous Mastitis (IGM) patients via pathological finding, IGM patient being not treated Exclusion criteria: Dissuasion of individuals for treatment procedures. 7 years 65 years Female N61 Inflammatory disorders of breast Treatment - Drugs Treatment - Surgery Intervention : Azithromycin and Prednisolone concomitant application of Azithromycin (250 milligram twice per week) and Prednisolone (40 milligram daily). Afterwards the protocol suggested Prednisolone treatment for eight weeks (40 mg per day) then it was tapered for 6 months control:Partial mastectomy Relapse. Timepoint: Patients were monthly examined for 15 months (from initiation of the intervention to 6 months after cessation of the intervention). Method of measurement: physical examination. Vice chancellor for research Isfahan University of Medical Sciences Approved 2012-05-10 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences,Hezar Jarib Ave.,Azadi Sq. Isfahan Iran (Islamic Republic of)