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IRCT20200608047694N1 IRCT 2020-07-21 Shiraz University of Medical Sciences Effectiveness of Local Injection (Bethametasone LA) combined with Systemic therapy (Methotraxate and Prednisolone)and Topical Steroids injection alone or Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis A Randomized Controlled Trial Study on the Effectiveness of Local Injection combined with with Systemic therapy and Topical Steroids injection alone or Systemic therapy alone in the Treatment of Idiopathic Granulomatous Mastitis 2020-05-23 anticipated 90 Complete https://irct.ir/trial/48903 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to avoid selection bias all the patients allocated to three groups by blocked randomization. It ensures that participants are assigned to groups with equal probability. In this study the size of each block is equal and consist of three patients. The treatments are randomly allocated to the experimental units inside each block and all treatments appear at least once in each block. 2-3 Idiopathic Granulomatous Mastitis. Intervention 1: Group one (N=30, systemic therapy plus local steroid injection) will be treated with Local steroid injection to the breast by the physician once a week for one to four times (betamethasone LA injection, each injection contains betamethasone Acetate at 3 mg and betamethasone disodium phosphate 3 mg/ml) and followed by systemic oral corticosteroid and Methotrexate (MTX) as systemic treatment (MTX 10 mg PO per week for 5 months and prednisolone 1mg/kg/day for the first month, then taper to 5 mg/day in 4 months following months). Intervention 2: Intervention group 2: Group two (N=30) will include systemic oral Corticosteroid and MTX as systemic treatment (MTX 10 mg PO per week for 2 months and Prednisolone 1mg/kg/day for the first month, then taper to 5 mg/day in 4 months following months). Intervention 3: Intervention group3: Group three (N=30) will be treat with Local steroid injection to the breast by the physician once a week for one to four times (Betamethasone LA injection, each injection contains Betamethasone Acetate at 3 mg and Betamethasone disodium phosphate 3 mg/ml). Yes - There is a plan to make this available What will be shared: Information about the main outcome of the study will be shared while maintaining the confidentiality of patient information. When: Data will be available,3months after publication To whom: Researchers affiliated with academic institutions Conditions: The use of data from this study in the form of higher and more complete sample size studies is not prohibited Where to obtain: Breast Diseases Research Center, Shahid Motahhrai Clinic affiliated to shiraz university of medical sciences How to obtain: Referring to the Breast Diseases Research center and after applying the request, the request will be evaluated in the approved meetings. Comments:
public Vahid Zangouri
Karim khan ZAnd, Namazi Square. Shahid motahhari Clinic
shiraz Iran (Islamic Republic of) 7134814336 +98 71 3612 1000 zangouri@sums.ac.ir Shiraz University of Medical Sciences scientific Vahid Zangouri
karimkhan zand avenue.namzai square. shahid motahhari clinic
shiraz Iran (Islamic Republic of) 7134814336 +98 71 3612 1000 zangouri@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Female patients with Idiopathic Granulomatosis Mastitis Female patients aged 18-65 Female patients with Idiopathic Granulomatosis Mastitis which require non-surgical treatment 18 years 65 years Female Female patients with Idiopathic Granulomatosis Mastitis who has abcess Female patients with Idiopathic Granulomatosis Mastitis which require surgical intervention or has breast cancer or other malignancy N61 Inflammatory disorders of breast Treatment - Drugs Treatment - Drugs Treatment - Drugs Group one (N=30, systemic therapy plus local steroid injection) will be treated with Local steroid injection to the breast by the physician once a week for one to four times (betamethasone LA injection, each injection contains betamethasone Acetate at 3 mg and betamethasone disodium phosphate 3 mg/ml) and followed by systemic oral corticosteroid and Methotrexate (MTX) as systemic treatment (MTX 10 mg PO per week for 5 months and prednisolone 1mg/kg/day for the first month, then taper to 5 mg/day in 4 months following months) Intervention group 2: Group two (N=30) will include systemic oral Corticosteroid and MTX as systemic treatment (MTX 10 mg PO per week for 2 months and Prednisolone 1mg/kg/day for the first month, then taper to 5 mg/day in 4 months following months) Intervention group3: Group three (N=30) will be treat with Local steroid injection to the breast by the physician once a week for one to four times (Betamethasone LA injection, each injection contains Betamethasone Acetate at 3 mg and Betamethasone disodium phosphate 3 mg/ml) The disappearance of inflammatory signs. Timepoint: All Patients will be followed weekly in first month and then monthly for 5 months for detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, worsened, or relapsed that will be evaluated by surgeon. Closure of fistula orifices. Timepoint: All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon. Disappearance of skin erosion. Timepoint: All Patients will be followed weekly in the first month and then monthly for 5 months to detect symptoms. Method of measurement: The clinical response is categorized into completely healed, inadequately healed, stable, and worsened that will be evaluated by the surgeon. Granulomatous mastitis recurrence in the Ipsilateral breast. Timepoint: All Patients will be exam by surgeon and sonography will be done for all of them at the last month of follow up. Method of measurement: The occurrence of Granulomatosis Mastitis will be assessed by the surgeon and doing sonography. Shiraz University of Medical Sciences Approved 2020-05-23 Ethics committee of Shiraz University of Medical Sciences Karimkhan Zand Avenue ,Namazee square, shahid motahhari clinic.Breast diseases research center SHIRAZ Fars Iran (Islamic Republic of)