[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627910":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":67,"collaborators":45,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":45,"maxAge":45,"enrollmentInfo":79,"targetDuration":45,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":45,"overallStatus":89,"whyStopped":45,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM Corticosteroid","ACTIVE_COMPARATOR","Steroids are used to treat GLM",[13],"Drug: Steroid",{"label":15,"type":10,"description":16,"interventionNames":17},"ARM Antibiotic","Antibiotics are used to treat GLM",[18],"Drug: Antibiotic",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Steroid","Once randomized into the steroid arm, oral therapy with Tab. Prednisolone 20mg BD will be given for 14days, Tab. Prednisolone 10mg BD will be given for 21 days, Tab. Prednisolone 5mg BD will be given for 14days and Tab. Prednisolone 2.5mg BD will be given for 7 days(tapering dose) will be used in this intervention compared to antibiotics which are used in other.\n\nIf the rate of response to oral steroids is slow and therapy prolonged, intralesional steroids (Inj. Triamcinalone 40mg) will be given as deemed required.",[9],[26,27],"Tab Prednisolone","Inj Triamcinalone",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Antibiotic","Once randomized into the antibiotic arm, dual oral antibiotic therapy with Ofloxacin 400mg and Clarithromycin 500mg will be used in this intervention compared to steroids which are used in other",[15],[33,34],"Tab Clarithromycin 500","Tab Ofloxacin 400",[36],{"name":37,"affiliation":38,"role":39},"Tushar Subhadarshan Mishra, MBBS,MS","AIIMS Bhubaneswar","PRINCIPAL_INVESTIGATOR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Maniteja Ravipati, MBBS","CONTACT","+91 7619508903",null,"maniteja.ravipati@gmail.com",{"name":37,"role":43,"phone":48,"phoneExt":45,"email":49},"+91 9438884251","surg_tushar@aiimsbhubaneswar.edu.in",[51],{"facility":38,"status":45,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Bhubaneswar","Odisha","751019","India","IN",{"type":58,"coordinates":59},"Point",[60,61],85.83385,20.27241,{"lat":61,"lon":60},[64],{"name":65,"role":43,"phone":66,"phoneExt":45,"email":46},"Maniteja R, MS","7619508903",{"type":39,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Tushar Subhadarshan Mishra","Head of the Department, Department of General Surgery","100627910","phase-1-antibiotics-vs-corticosteroids-in-treatment-of-granulomatous-lobular-mastitis-100627910",false,"NCT07454772","Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis","Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trail","GRANMAS","Inclusion Criteria:\n\n* Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.\n\nExclusion Criteria:\n\n* Declining to participate in the study\n* Pregnant or lactating women\n* Patient already on antibiotic\u002Fsteroid therapy and are responding to treatment\n* Known immunosuppression or diabetes mellitus uncontrolled\n* Patient already on immunosuppression therapy for any other disorder\n* Lost to follow-up before 3 months post-treatment\n* Allergic to one of the antibiotics\u002Fsteroids which will be used\n* Contraindications to oral steroids therapy\n* Contraindications to methotrexate therapy","FEMALE",{"count":80,"type":81},72,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","The goal of this clinical trial is to find the most effective and safe medical treatment for Granulomatous Lobular Mastitis (GLM) - a rare, chronic inflammatory breast disease that affects young and middle-aged women, often following childbirth.\n\nThe main questions it aims to answer are:\n\nDoes an antibiotic regimen (clarithromycin, ofloxacin, rifaximin) lead to faster and complete healing (Complete Clinical Response) compared to steroids?\n\nDo steroids (prednisolone in tapering doses) provide better symptom control or cause more side effects?\n\nResearchers will compare the antibiotic group (Group A) and the steroid group (Group B) to see which treatment results in quicker recovery, fewer side effects, and lower recurrence rates.\n\nParticipants will:\n\nReceive a 14-day antibiotic trial initially (screening phase).\n\nIf no improvement, be randomly assigned to:\n\nGroup A (Antibiotic therapy) - Clarithromycin, Ofloxacin, Rifaximin for 8 weeks, or\n\nGroup B (Steroid therapy) - Prednisolone in tapering doses for 8 weeks.\n\nUndergo evaluation after 2 months:\n\nIf not fully recovered, receive Methotrexate + Folic acid for another 8 weeks.\n\nIf still no improvement, switch to the alternate treatment or undergo surgery if required.\n\nAttend regular follow-ups for 6 months for clinical assessment and monitoring of side effects.\n\nThis 2-year study aims to develop a standardized, step-by-step treatment protocol for GLM, helping improve outcomes and reduce unnecessary surgeries for affected women.",[88],"Granulomatous Mastitis","NOT_YET_RECRUITING","2026-03-04",{"date":92,"type":93},"2026-03-06","ACTUAL",{"date":95,"type":81},"2026-03-15",{"date":97,"type":81},"2027-07-04",{"name":5,"class":6},1]