Health Condition 1: N610- Mastitis without abscess Health Condition 2: N611- Abscess of the breast and nipple
Conditions
Interventions
Intervention1: Corticosteroid: Tab. PREDNISOLONE 20mg 14 days
Tab. PREDNISOLONE 10mg 21 days
Tab. PREDNISOLONE 5mg 14 days
Tab. PREDNISOLONE 2.5mg 7 days
Control Intervention1: Antibiotics: Tab. CLARI
Sponsors
Dr Tushar Subhadarshan Mishra
Eligibility
Inclusion criteria
Inclusion criteria: Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.
Exclusion criteria
Exclusion criteria: 1. Declining to participate in the study 2. Pregnant or lactating women 3. Patient already on antibiotic/steroid therapy and are responding to treatment 4. Known immunosuppression or diabetes mellitus uncontrolled 5. Patient already on immunosuppression therapy for any other disorder 6. Lost to follow-up before 3 months post-treatment 7. Allergic to one of the antibiotics/steroids which will be used 8. Contraindications to oral steroids therapy 9. Contraindications to methotrexate therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of antibiotics vs corticosteroids in achieving Complete Clinical Response (CCR) in GLM patients at two months of the treatment started in the adaptive randomized armTimepoint: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of each treatment regimen.Timepoint: 2 months;To assess the role of surgery in the treatment of GLM A) To determine the proportion patients requiring surgery B) Quantum of surgery needed (I and D/Resection/mastectomy) C) Number of patients have recurrence after surgeryTimepoint: 2 months;To assess the role of combination immunosuppressive therapy in the treatment of GLM A) To determine the proportion of patient requiring combination immunosuppressive therapy B) Average duration of immunosuppressive therapy required C) To determine the Indications of immunosuppressive therapy (failure to achieve CCR within 2 months/Relapse/cure, side effects of primary medications)Timepoint: 2 months;Histological pattern (neutrophilic/lymphocytic) vs Response to therapyTimepoint: 2 months;To have a cause of treatment delay (diagnostic dilemma/improper therapy (wrong antibiotic/wrong steroid/wrong duration)Timepoint: 2 months | — |
Countries
India
Contacts
Public ContactDr Maniteja R
AIIMS Bhubaneswar
Outcome results
None listed