[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632358":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":53,"collaborators":29,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":29,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":29,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":29,"overallStatus":77,"whyStopped":29,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Shengjing Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","ACTIVE_COMPARATOR","Standard Medication",[13],"Drug: Standard Medication",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental Group 1","EXPERIMENTAL","Sanyong Jiedu Granules",[19],"Drug: Sanyong Jiedu Granules",{"label":21,"type":16,"description":22,"interventionNames":23},"Experimental Group 2","Combination of Sanyong Jiedu Granules with Standard Medication",[19,13],[25,30],{"type":26,"name":17,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Prescribe Sanyong Jiedu Granules, to be taken with hot water, 10 g per dose, three times daily, for a course of 56 days or until symptoms have completely resolved or stabilised.",[15,21],null,{"type":26,"name":11,"description":31,"armGroupLabels":32,"otherNames":29},"Treatment regimen for plasma cell mastitis:\n\nFor patients without cephalosporin allergy: oral cefuroxime axetil tablets (brand name: Dalixin®), 250 mg twice daily, plus oral metronidazole tablets, 0.4 g three times daily, for 7-10 consecutive days.\n\nFor patients allergic to cephalosporins: oral levofloxacin tablets, 0.5 g once daily, plus oral metronidazole tablets, 0.4 g three times daily, for 7-14 consecutive days.\n\nTreatment regimen for granulomatous lobular mastitis:\n\nOral methylprednisolone tablets (brand name: Metrol®), 20 mg once daily for 14 consecutive days; following symptom relief, the dose should be gradually reduced every 1-2 weeks to 16, 12, 8, and 4 mg\u002Fday, and continued for 56 days or until symptoms are completely resolved or stabilised.",[9,21],[34],{"name":35,"role":36,"phone":37,"phoneExt":29,"email":38},"Xiaoyu Gao","CONTACT","18940250811","gaoxiaoyu@sj-hospital.org",[40],{"facility":41,"status":29,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":29},"Shengjing Hospital of China Medical University","Shenyang","Liaoning","110022","China","CN",{"type":48,"coordinates":49},"Point",[50,51],123.43278,41.79222,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Caigang Liu","Postdoctoral,Chief Physician","100632358","efficacy-and-safety-of-sanyong-jiedu-granules-in-treating-lumps-type-non-lactational-mastiti-100632358",false,"NCT07512648","Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastiti","Efficacy and Safety of Sanyong Jiedu Granules in Treating Lumps-Type Non-Lactational Mastitis: A Prospective Multicentre Randomised Controlled Trial","Inclusion Criteria:\n\n* Women aged 20-50 years (inclusive) who are not in lactation or pregnancy (as confirmed\n* Meeting the diagnostic criteria for non-lactational mastitis\n* In the mass phase of non-lactational mastitis, with no surface ulceration or only minor ulceration or microabscesses, but without sinus tract or fistula formation\n* Diagnosed as \"exuberant heat-toxin syndrome\" in Traditional Chinese Medicine (TCM) syndrome differentiation\n* nformed consent obtained and signed by the subject\n\nExclusion Criteria:\n\n* Patients with intolerance or poor compliance to the investigational drug, or known hypersensitivity to any component of this regimen\n* Patients with clinically or laboratory-confirmed severe cardiac, hepatic, or renal dysfunction, or those with severe complications, active infections, persistent fever, severe bleeding tendency, or hematopoietic abnormalities\n* Patients diagnosed with breast cancer by pathological biopsy\n* Confirmed as tuberculous granuloma by pathogen examination\n* Pregnant and lactating women, as well as women of childbearing age who are fertile but unwilling to use effective contraception throughout the trial period\n* A clear history of neurological or psychiatric disorders, including epilepsy or dementia;Suspected or confirmed history of alcohol or drug abuse;Participants deemed unsuitable for the study by the investigators","FEMALE","20 Years","50 Years",{"count":68,"type":69},210,"ESTIMATED","INTERVENTIONAL",[72],"NA","To evaluate the efficacy and safety of Sanyong Jiedu Granules in treating non-lactational mastitis with lump formation, and to investigate the relationship between its clinical efficacy and treatment duration.",[75,76],"Plasmacytic Mastitis","Granulomatous Lobular Mastitis","NOT_YET_RECRUITING","2026-03-30",{"date":80,"type":81},"2026-04-06","ACTUAL",{"date":83,"type":69},"2026-03-20",{"date":85,"type":69},"2028-07-31",{"name":55,"class":6},1]