[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jianhua Zhou\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100498639","phase-4-the-efficacy-and-safety-of-prednisone-combined-with-huaiqihuang-granule-for-primary-nephrotic-syndrome-in-children-100498639",false,"NCT05772871","The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children","Compare the Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule Versus Combined With Levamisole for Primary Nephrotic Syndrome in Children: A Prospective, Multi-center, Randomized, Double-blind, Non-inferiority Study","Inclusion Criteria:\n\n* Age from 1.5 to 18 years;\n* According to the Evidence-based Guideline for Diagnosis and Treatment of Hormone-sensitive, Relapsed\u002Fdependent Nephrotic Syndrome in Children (2016), children diagnosed with PNS;\n* At enrollment, estimated glomerular filtration rate (eGFR)≥90ml\u002Fmin\u002F1.73m2；\n* At enrollment, serum albumin level below 30g\u002FL, and morning urine protein is 4+ or urinary albumin\u002Fcreatinine ratio (ACR)≥2.0g\u002Fg;\n* Volunteered to participate in this study and signed informed consent. For children less than 8 years, legal guardians need to sign the informed consent.\n\nExclusion Criteria:\n\n* Children who were diagnosed as steroid-resistant NS;\n* Patients who received Prednisone, other corticosteroids (like Prednisolone, Methylprednisolone), or immunosuppressants (Tacrolimus, Mycophenolate Mofetil, Cyclosporine A, Rituximab, Cyclophosphamide) within 3 months before enrollment;\n* Secondary NS caused by lupus nephritis, hepatitis B associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;\n* With combined diseases of autoimmune disorder or primary immunodeficiency or malignancy;\n* With combined diseases of the cardiovascular, liver, hematopoietic system, mental disorders, and other serious diseases;\n* With serious infectious diseases (like tuberculosis) in the past or at present;\n* With combined diseases of Human immunodeficiency virus (HIV), hepatitis B and \u002For C virus (HBV, HCV), and other active virus infections;\n* History of diabetes;\n* Abnormal liver function: alanine aminotransferase and aspartate aminotransferase levels exceed twice the upper limit of the normal range;\n* Participation in other ongoing clinical trials;\n* Other reasons that the researcher considers unsuitable to participate in this study.","ALL","18 Months","18 Years",{"count":20,"type":21},402,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This non-inferiority study aims to compare the efficacy of Prednisone combined with Huaiqihuang Granule against Prednisone combined with Levamisole in the treatment of primary nephrotic syndrome (PNS) in children.",[27],"Nephrotic Syndrome in Children",[29,30,31],"Huaiqihuang granule","Children","Nephrotic syndrome","RECRUITING","2024-06-20",{"date":35,"type":36},"2024-06-21","ACTUAL",{"date":38,"type":36},"2023-04-26",{"date":40,"type":21},"2025-10-30",{"name":42,"class":43},"Jianhua Zhou","OTHER",26,""]