[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566419":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":79,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Short duration","ACTIVE_COMPARATOR","6-month prednisolone (shorter treatment)",[13],"Drug: Prednisolone",{"label":15,"type":10,"description":16,"interventionNames":17},"Long duration","12-month prednisolone (longer treatment)",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Prednisolone","An initial dose of 40 mg\u002Fday will be administered for 1 week, followed by 30 mg\u002Fday for 1 week, 20 mg\u002Fday for 6 weeks, 15 mg\u002Fday for 4 weeks, 10 mg\u002Fday for 8 weeks, 5 mg\u002Fday for 4 weeks, 2.5 mg\u002Fday for 2 weeks after which the drug will be discontinued (cumulative prednisolone dose, 2485 mg).",[9],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"An initial dose of 40 mg\u002Fday will be administered for 1 week, followed by 30 mg\u002Fday for 1 week, 20 mg\u002Fday for 6 weeks, 15 mg\u002Fday for 4 weeks, 10 mg\u002Fday for 14 weeks, 5 mg\u002Fday for 24 weeks, 2.5 mg\u002Fday for 2 weeks after which the drug will be discontinued (cumulative prednisolone dose, 3605 mg).",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Sahajal Dhooria, MD, DM","CONTACT","+917087002015","sahajal@gmail.com",[35],{"facility":36,"status":24,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Post Graduate Institute of Medical Education and Research","Chandigarh","160012","India","IN",{"type":42,"coordinates":43},"Point",[44,45],76.7884,30.73629,{"lat":45,"lon":44},[48],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Sahajal Dhooria","Associate Professor","100566419","phase-4-prednisolone-for-12-versus-6-months-to-treat-pulmonary-sarcoidosis-100566419",false,"NCT06654934","Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis","Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis: a Randomized Trial","DURASARC","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Computed tomography of the chest consistent with a diagnosis of sarcoidosis of the lung\u002Fmediastinal lymph nodes\n* Diagnosis of sarcoidosis made on cytological or histological samples\n* Having significant symptoms requiring immunosuppressive treatment and\u002For having reduced lung function (defined as forced vital capacity or forced expiratory volume in one second (FEV1) less than 80% predicted) or an extrapulmonary manifestation of the disease requiring treatment with low-medium dose glucocorticoids\n* Onset of symptoms within two years of study entry\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Subjects having any manifestation requiring high dose steroid treatment (this includes symptomatic neurosarcoidosis, life threatening cardiac sarcoidosis, vision threatening posterior uveitis or other forms of vision threatening ocular sarcoidosis)\n* Having absolute contraindication for prednisone (this includes untreated glaucoma, uncontrolled diabetes mellitus, untreated infections, untreated severe psychiatric disorders)\n* Unwilling to participate in the study\n* Having received glucocorticoids (prednisolone equivalent \\>15 mg\u002Fday) for more than three weeks in the preceding year","ALL","18 Years",{"count":64,"type":65},100,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","In this study, the efficacy and safety of treating pulmonary sarcoidosis with 12 months vs. 6 months of prednisolone will be compared. The hypothesis is that longer treatment DURAtion would be more effective in preventing treatment failure or early relapse in SARCoidosis (DURASARC trial). The premise of this hypothesis is that even small doses of prednisolone given over longer periods can effectively suppress disease activity in sarcoidosis without a significant increase in adverse effects.",[71],"Sarcoidosis",[73,74,75,76,77,78],"granulomatous disease","interstitial lung disease","diffuse lung disease","tuberculosis","steroid","ILD","NOT_YET_RECRUITING","2024-10-21",{"date":82,"type":83},"2024-10-23","ACTUAL",{"date":85,"type":65},"2024-11",{"date":87,"type":65},"2026-12",{"name":5,"class":6},1]