[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627910":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":54,"studyPopulation":47,"armGroups":55,"interventions":67,"overallOfficials":83,"centralContacts":88,"locations":97,"responsibleParty":114,"collaborators":47,"id":117,"slug":47,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":47,"maxAge":47,"enrollmentInfo":125,"targetDuration":47,"studyType":128,"phases":129,"briefSummary":132,"conditions":133,"keywords":47,"overallStatus":135,"whyStopped":47,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Primary outcome","To compare the efficacy of antibiotics vs corticosteroids in achieving Complete Clinical Response (CCR) via clinical and radiological assessment in GLM patients at two months of the treatment started in the adaptive randomized arm.\n\nCCR will be defined as no clinical signs and symptoms of the disease and no recurrence for 6 weeks.","2 months",[14,17,20,23,26,29,32,35,38,41,44],{"measure":15,"description":16,"timeFrame":12},"To assess the safety and tolerability of each treatment regimen","To assess the safety and tolerability of each treatment regimen via clinical assessment leading to the detection of any side effects, namely weight gain, skin changes, diabetes mellitus, bone pain, menstrual irregularities, hirsuitism, cataract, glaucoma, joint pains, tendonitis, skin ulcers, and heart rhythm changes.\n\nAny of the above side effects, debilitating enough to warrant stoppage of therapy will define tolerability. Development of irreversible side effects will define safety of the treatment regimen.",{"measure":18,"description":19,"timeFrame":12},"To assess the the proportion of patients requiring surgery in the treatment of GLM","Determining the proportion of patients requiring surgery, based on surgical procedures performed on basis of clinical examination findings suggestive of abscess.\n\nAspiration and minisuction drain(6 french aspiration catheter\u002Fpigtail) will be not be considered as a surgical procedure",{"measure":21,"description":22,"timeFrame":12},"To assess the role of different quantum of surgery needed (Incision and Drainage\u002FResection\u002Fmastectomy) in the treatment of GLM","Determining the Quantum of surgery needed (Incision and Drainage\u002FResection\u002Fmastectomy), based on surgical procedures performed on basis of clinical examination findings suggestive of abscess.\n\nAspiration and minisuction drain(6 french aspiration catheter\u002Fpigtail) will be not be considered as a surgical procedure",{"measure":24,"description":25,"timeFrame":12},"To assess the number of patients have recurrence after surgery in the treatment of GLM","Determining the number of patients have recurrence after surgery performed in the institution or outside, based on surgical procedures performed on basis of clinical examination findings suggestive of abscess.\n\nAspiration and minisuction drain(6 french aspiration catheter\u002Fpigtail) will be not be considered as a surgical procedure",{"measure":27,"description":28,"timeFrame":12},"To assess the number of patients requiring Aspiration\u002F minisuction drain(6 french aspiration catheter\u002Fpigtail) in the treatment of GLM","Determining the number of patients requiring Aspiration\u002F minisuction drain(6 french aspiration catheter\u002Fpigtail) on basis of clinical examination findings suggestive of abscess.",{"measure":30,"description":31,"timeFrame":12},"To assess the failure rate of aspiration\u002F minisuction drain(6 french aspiration catheter\u002Fpigtail) in the treatment of GLM","Determining the proportion of aspiration\u002Fminisuction drain failures from procedures performed on basis of clinical examination findings suggestive of abscess.",{"measure":33,"description":34,"timeFrame":12},"To determine the Indications of immunosuppressive therapy in the treatment of GLM","To determine the indications of immunosuppressive therapy (failure to achieve CCR within 2 months\u002FRelapse\u002Fcure, side effects of primary medications), started after non response to intervention arm drugs",{"measure":36,"description":37,"timeFrame":12},"To To determine the proportion of patient requiring combination immunosuppressive therapy in the treatment of GLM","To determine the proportion of patient requiring combination immunosuppressive therapy started after non response to intervention arm drugs",{"measure":39,"description":40,"timeFrame":12},"To determine the average duration of immunosuppressive therapy required in the treatment of GLM","Average duration of immunosuppressive therapy required, started after non response to intervention arm drugs",{"measure":42,"description":43,"timeFrame":12},"Histological pattern (neutrophilic\u002Flymphocytic\u002Fmixed)","To compare the proportion of patients with each of the histological variety (neutrophilic\u002Flymphocytic\u002Fmixed) of GLM attaining complete response to therapy in each arm.",{"measure":45,"description":46,"timeFrame":12},"Proportion of CCR obtained in each histological pattern (neutrophilic\u002Flymphocytic)","To assess the proportion of CCR obtained in each histological pattern (neutrophilic\u002Flymphocytic).",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":47},"NONE","What is this study about?\n\nThis research is being done at AIIMS Bhubaneswar to find the best medical treatment for a breast condition called Granulomatous Lobular Mastitis (GLM).\n\nGLM is a rare, long-lasting inflammation of the breast that mainly affects young and middle-aged women, often those who have recently had children. It can look very similar to breast cancer or a breast abscess, causing anxiety and sometimes unnecessary surgery.\n\nCommon symptoms include:\n\nPainful or painless breast lump\n\nSwelling, redness, or abscess (collection of pus)\n\nDischarge from the nipple or retraction (nipple pulled inward)\n\nSkin changes over the breast It can occur in one or both breasts and may come back after treatment.\n\nWhy is this study important?\n\nAt present, there is no single, standard treatment for GLM. Doctors use antibiotics, steroids, immunosuppressants (like methotrexate), or surgery - but the results vary widely. Some medicines help one patient but not another, and some cause unwanted side effects or recurrences.\n\nThis study aims to compare antibiotics and steroids directly, to identify which gives better and faster healing with fewer side effects. The goal is to develop a clear, step-by-step treatment plan for all patients with GLM.\n\nWhat will happen in this study? Who can take part?\n\nWomen diagnosed with GLM by biopsy (tissue test).\n\nParticipants must be willing to attend regular follow-ups.\n\nWomen who are pregnant, breastfeeding, diabetic (uncontrolled), on other immunosuppressive treatment, or allergic to study drugs cannot participate.\n\nHow the study works:\n\nFirst step (screening):\n\nAll participants will receive a short course of antibiotics for 14 days.\n\nIf the infection improves, treatment continues outside the study.\n\nIf it doesn't improve, the person will be included in the main trial.\n\nRandom assignment:\n\nPatients will be randomly divided into two groups:\n\nGroup A - Antibiotic group: Receives clarithromycin, ofloxacin, and rifaximin tablets for 8 weeks.\n\nGroup B - Steroid group: Receives prednisolone (steroid tablets) in reducing doses for 8 weeks.\n\nReview after 2 months:\n\nDoctors will check whether the breast swelling and pain are gone.\n\nIf completely cured (called Complete Clinical Response or CCR), medicines are stopped.\n\nIf not cured, the patient is given an additional medicine (methotrexate + folic acid) for 8 weeks.\n\nIf still not improved:\n\nThe treatment groups are switched (antibiotic patients receive steroids, and vice versa).\n\nIf there's still no recovery, surgery (like abscess drainage or lump removal) will be considered.\n\nThroughout the study, symptoms, side effects, and any need for surgery will be recorded carefully.\n\nHow long does participation last?\n\nEach participant will be followed for around 6 months - this includes treatment, monitoring, and follow-up visits.\n\nPossible benefits for participants\n\nRegular medical check-ups, follow-ups, and investigations by specialist doctors.\n\nChance of receiving an effective, well-monitored treatment plan.\n\nEarly detection of complications and quick medical management.\n\nContribution to medical knowledge that may help future patients avoid prolonged or incorrect treatment.\n\nPossible side effects or risks\n\nAll medicines used in this study are commonly prescribed and generally safe under supervision.\n\nHowever, possible side effects may include:\n\nFor antibiotics: stomach upset, nausea, mild diarrhea, or allergy (rare).\n\nFor steroids: weight gain, bloating, mood changes, increased appetite, or joint pain.\n\nFor methotrexate: mild fatigue, nausea, or rare liver enzyme changes (monitored closely).\n\nDoctors will monitor all participants closely and adjust or stop treatment if any problems arise.\n\nAny abscess or fluid collection will be drained if needed, and pain will be managed with appropriate medicines.\n\nConfidentiality and voluntary participation\n\nAll personal information will be kept strictly confidential. Participants' names will not appear in any reports or publications. Joining this study is completely voluntary. You may leave the study at any time without affecting your future medical care.\n\nCosts and compensation\n\nAll investigations and medicines that are part of routine care are free or low-cost.\n\nThe average expected expense is about ₹2500, which includes only the patient's regular medical costs.\n\nIf any research-related injury occurs, the hospital will provide free treatment.\n\nExpected outcomes\n\nBy comparing results between antibiotics and steroids, this study aims to:\n\nIdentify which treatment helps more women achieve complete healing faster.\n\nUnderstand which drugs have fewer side effects.\n\nReduce the need for surgery and recurrence.\n\nDevelop a standardized treatment protocol for GLM.\n\nIf antibiotics are found to be equally effective or better, they could become the first-line, low-cost, safer option - especially in areas with limited resources.\n\nIf steroids prove superior, their dosage and duration can be refined to minimize side effects.\n\nStudy time - 2 years",[56,62],{"label":57,"type":58,"description":59,"interventionNames":60},"ARM Corticosteroid","ACTIVE_COMPARATOR","Steroids are used to treat GLM",[61],"Drug: Steroid",{"label":63,"type":58,"description":64,"interventionNames":65},"ARM Antibiotic","Antibiotics are used to treat GLM",[66],"Drug: Antibiotic",[68,76],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"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.",[57],[74,75],"Tab Prednisolone","Inj Triamcinalone",{"type":69,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"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",[63],[81,82],"Tab Clarithromycin 500","Tab Ofloxacin 400",[84],{"name":85,"affiliation":86,"role":87},"Tushar Subhadarshan Mishra, MBBS,MS","AIIMS Bhubaneswar","PRINCIPAL_INVESTIGATOR",[89,94],{"name":90,"role":91,"phone":92,"phoneExt":47,"email":93},"Maniteja Ravipati, MBBS","CONTACT","+91 7619508903","maniteja.ravipati@gmail.com",{"name":85,"role":91,"phone":95,"phoneExt":47,"email":96},"+91 9438884251","surg_tushar@aiimsbhubaneswar.edu.in",[98],{"facility":86,"status":47,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Bhubaneswar","Odisha","751019","India","IN",{"type":105,"coordinates":106},"Point",[107,108],85.83385,20.27241,{"lat":108,"lon":107},[111],{"name":112,"role":91,"phone":113,"phoneExt":47,"email":93},"Maniteja R, MS","7619508903",{"type":87,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Tushar Subhadarshan Mishra","Head of the Department, Department of General Surgery","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":126,"type":127},72,"ESTIMATED","INTERVENTIONAL",[130,131],"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.",[134],"Granulomatous Mastitis","NOT_YET_RECRUITING","2026-03-04",{"date":138,"type":139},"2026-03-06","ACTUAL",{"date":141,"type":127},"2026-03-15",{"date":143,"type":127},"2027-07-04",{"name":5,"class":6},1]