[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498639":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":46,"centralContacts":50,"locations":55,"responsibleParty":351,"collaborators":354,"id":358,"slug":359,"hasResults":360,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":29,"eligibilityCriteria":364,"healthyVolunteers":360,"sex":365,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":29,"studyType":371,"phases":372,"briefSummary":374,"conditions":375,"keywords":377,"overallStatus":58,"whyStopped":29,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Prednisone, Huaiqihuang granule, and Levamisole placebo","EXPERIMENTAL","In this group, patients will take Prednisone, Huaiqihuang granule, and Levamisole placebo.",[13,14,15],"Drug: Huaiqihuang granule","Drug: Prednisone","Drug: Levamisole placebo",{"label":17,"type":18,"description":19,"interventionNames":20},"Prednisone, Levamisole, and Huaiqihuang granule placebo","PLACEBO_COMPARATOR","In this group, patients will take Prednisone, Levamisole, and Huaiqihuang granule placebo.",[14,21,22],"Drug: Levamisole","Drug: Huaiqihuang Granule placebo",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Huaiqihuang granule","Huaiqihuang Granule, oral administration, recommended daily dose: for body weight \\\u003C10 kg, 5g, twice a day; for 10 kg ≤ body weight \\\u003C20 kg, 10g, twice a day; for 20 kg≤body weight \\\u003C30 kg, 15g, twice a day; for 30 kg≤body weight \\\u003C50 kg, 20g, twice a day; for body weight\\>50 kg, 30g, twice a day. Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Prednisone","Prednisone, oral administration, recommended dose: 2mg\u002Fkg\u002Fd (maximum 60 mg\u002Fd) for 4 weeks followed by 2 mg\u002Fkg (maximum 60mg) on alternate days for the other 4 weeks. If patients have relapsed during reducing dosage or withdrawal, the patients will receive Prednisone for 8 weeks again \\[2mg\u002Fkg\u002Fd (maximum 60 mg\u002Fd) for 4 weeks followed by 2 mg\u002Fkg (maximum 60mg) on alternate days for the other 4 weeks\\]. If a second relapse is observed, patients will receive immunosuppressants and then withdraw from the trial.",[9,17],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Levamisole placebo","Levamisole placebo, 1.25 mg\u002Fkg. once daily. Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Levamisole","Levamisole, 1.25 mg\u002Fkg. once daily. Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.",[17],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Huaiqihuang Granule placebo","Huaiqihuang Granule placebo, oral administration, recommended daily dose: for body weight \\\u003C10 kg, 5g, twice a day; for 10 kg ≤ body weight \\\u003C20 kg, 10g, twice a day; for 20 kg≤body weight \\\u003C30 kg, 15g, twice a day; for 30 kg≤body weight \\\u003C50 kg, 20g, twice a day; for body weight\\>50 kg, 30g, twice a day. Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.",[17],[47],{"name":48,"affiliation":5,"role":49},"Jianhua Zhou, Dr.","PRINCIPAL_INVESTIGATOR",[51],{"name":48,"role":52,"phone":53,"phoneExt":29,"email":54},"CONTACT","86+13367266559","jhzhou@tjh.tjmu.edu.cn",[56,72,84,96,104,116,128,140,152,163,171,183,191,203,215,227,239,250,262,274,286,293,304,316,328,340],{"facility":57,"status":58,"city":59,"state":60,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Anhui Children's Hospital","RECRUITING","Hefei","Anhui","China","CN",{"type":64,"coordinates":65},"Point",[66,67],117.28083,31.86389,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":29,"phoneExt":29,"email":29},"Fang Deng",{"facility":73,"status":58,"city":74,"state":75,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Children's Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality",{"type":64,"coordinates":77},[78,79],106.55771,29.56026,{"lat":79,"lon":78},[82],{"name":83,"role":52,"phone":29,"phoneExt":29,"email":29},"Mo Wang",{"facility":85,"status":58,"city":86,"state":87,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Fujian Children's Hospital","Fuzhou","Fujian",{"type":64,"coordinates":89},[90,91],119.30611,26.06139,{"lat":91,"lon":90},[94],{"name":95,"role":52,"phone":29,"phoneExt":29,"email":29},"Zihua Yu",{"facility":97,"status":58,"city":86,"state":87,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"People's Liberation Army Joint Logistics Force No. 900 Hospital",{"type":64,"coordinates":99},[90,91],{"lat":91,"lon":90},[102],{"name":103,"role":52,"phone":29,"phoneExt":29,"email":29},"Xiaojing Nie",{"facility":105,"status":58,"city":106,"state":107,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"The First Affiliated Hospital, Sun Yat-sen University","Guangzhou","Guangdong",{"type":64,"coordinates":109},[110,111],113.25,23.11667,{"lat":111,"lon":110},[114],{"name":115,"role":52,"phone":29,"phoneExt":29,"email":29},"Xiaoyun Jiang",{"facility":117,"status":58,"city":118,"state":119,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Hebei Children's Hospital","Shijiazhuang","Hebei",{"type":64,"coordinates":121},[122,123],114.47861,38.04139,{"lat":123,"lon":122},[126],{"name":127,"role":52,"phone":29,"phoneExt":29,"email":29},"Dongfeng Zhang",{"facility":129,"status":58,"city":130,"state":131,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Harbin Children's Hospital","Harbin","Heilongjiang",{"type":64,"coordinates":133},[134,135],126.65,45.75,{"lat":135,"lon":134},[138],{"name":139,"role":52,"phone":29,"phoneExt":29,"email":29},"Fang Ning",{"facility":141,"status":58,"city":142,"state":143,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"The First Affiliated Hospital of Xinxiang Medical University","Xinxiang","Henan",{"type":64,"coordinates":145},[146,147],113.80151,35.19033,{"lat":147,"lon":146},[150],{"name":151,"role":52,"phone":29,"phoneExt":29,"email":29},"Ziming Han",{"facility":153,"status":58,"city":154,"state":143,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Henan Children's Hospital","Zhengzhou",{"type":64,"coordinates":156},[157,158],113.64861,34.75778,{"lat":158,"lon":157},[161],{"name":162,"role":52,"phone":29,"phoneExt":29,"email":29},"Cuihua Liu",{"facility":164,"status":58,"city":154,"state":143,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":165,"geoPoint":167,"contacts":168},"The First Affliated Hospital of Zhengzhou University",{"type":64,"coordinates":166},[157,158],{"lat":158,"lon":157},[169],{"name":170,"role":52,"phone":29,"phoneExt":29,"email":29},"Jianhua Zhang",{"facility":172,"status":58,"city":173,"state":174,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei",{"type":64,"coordinates":176},[177,178],114.26667,30.58333,{"lat":178,"lon":177},[181],{"name":182,"role":52,"phone":29,"phoneExt":29,"email":29},"Jianhua Zhou",{"facility":184,"status":58,"city":173,"state":174,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":185,"geoPoint":187,"contacts":188},"Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"type":64,"coordinates":186},[177,178],{"lat":178,"lon":177},[189],{"name":190,"role":52,"phone":29,"phoneExt":29,"email":29},"Xiaowen Wang",{"facility":192,"status":58,"city":193,"state":194,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Hunan Children's Hospital","Changsha","Hunan",{"type":64,"coordinates":196},[197,198],112.97087,28.19874,{"lat":198,"lon":197},[201],{"name":202,"role":52,"phone":29,"phoneExt":29,"email":29},"Zhihui Li",{"facility":204,"status":58,"city":205,"state":206,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Children's Hospital of Soochow University","Suzhou","Jiangsu",{"type":64,"coordinates":208},[209,210],120.59538,31.30408,{"lat":210,"lon":209},[213],{"name":214,"role":52,"phone":29,"phoneExt":29,"email":29},"Xiaozhong Li",{"facility":216,"status":58,"city":217,"state":218,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Baiqiu'en First Hospital of Jilin University","Changchun","Jilin",{"type":64,"coordinates":220},[221,222],125.32278,43.88,{"lat":222,"lon":221},[225],{"name":226,"role":52,"phone":29,"phoneExt":29,"email":29},"Kaishu Zhao",{"facility":228,"status":58,"city":229,"state":230,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Dalian Women and Children's Medical Centre","Dalian","Liaoning",{"type":64,"coordinates":232},[233,234],121.60222,38.91222,{"lat":234,"lon":233},[237],{"name":238,"role":52,"phone":29,"phoneExt":29,"email":29},"Mei Han",{"facility":240,"status":58,"city":241,"state":230,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Shengjing Hospital of China Medical University","Shenyang",{"type":64,"coordinates":243},[244,245],123.43278,41.79222,{"lat":245,"lon":244},[248],{"name":249,"role":52,"phone":29,"phoneExt":29,"email":29},"Yue Du",{"facility":251,"status":58,"city":252,"state":253,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Shandong Provincial Hospital","Jinan","Shandong",{"type":64,"coordinates":255},[256,257],116.99722,36.66833,{"lat":257,"lon":256},[260],{"name":261,"role":52,"phone":29,"phoneExt":29,"email":29},"Shunzhen Sun",{"facility":263,"status":58,"city":264,"state":265,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Shanghai Children's Hospital","Shanghai","Shanghai Municipality",{"type":64,"coordinates":267},[268,269],121.45806,31.22222,{"lat":269,"lon":268},[272],{"name":273,"role":52,"phone":29,"phoneExt":29,"email":29},"Wenyan Huang",{"facility":275,"status":58,"city":276,"state":277,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Shanxi Children's Hospital","Taiyuan","Shanxi",{"type":64,"coordinates":279},[280,281],112.56028,37.86944,{"lat":281,"lon":280},[284],{"name":285,"role":52,"phone":29,"phoneExt":29,"email":29},"Lijun Zhao",{"facility":287,"status":58,"city":288,"state":289,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":29,"geoPoint":29,"contacts":290},"West China Second Hospital of Sichuan University","Chengde","Sichuan",[291],{"name":292,"role":52,"phone":29,"phoneExt":29,"email":29},"Yuhong Tao",{"facility":294,"status":58,"city":295,"state":289,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Chengdu Women's and Children's Central Hospital","Chengdu",{"type":64,"coordinates":297},[298,299],104.06667,30.66667,{"lat":299,"lon":298},[302],{"name":303,"role":52,"phone":29,"phoneExt":29,"email":29},"Shipin Feng",{"facility":305,"status":58,"city":306,"state":307,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Tianjin Children's Hospital","Tianjin","Tianjin Municipality",{"type":64,"coordinates":309},[310,311],117.17667,39.14222,{"lat":311,"lon":310},[314],{"name":315,"role":52,"phone":29,"phoneExt":29,"email":29},"Wenhong Wang",{"facility":317,"status":58,"city":318,"state":319,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Xinjiang Uiger Municipal People's Hospital","Ürümqi","Xinjiang",{"type":64,"coordinates":321},[322,323],87.60046,43.80096,{"lat":323,"lon":322},[326],{"name":327,"role":52,"phone":29,"phoneExt":29,"email":29},"Feiyan Wang",{"facility":329,"status":58,"city":330,"state":331,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Children's Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":64,"coordinates":333},[334,335],120.16142,30.29365,{"lat":335,"lon":334},[338],{"name":339,"role":52,"phone":29,"phoneExt":29,"email":29},"Jianhua Mao",{"facility":341,"status":58,"city":342,"state":331,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Ningbo Women's and Children's Hospital","Ningbo",{"type":64,"coordinates":344},[345,346],121.54945,29.87819,{"lat":346,"lon":345},[349],{"name":350,"role":52,"phone":29,"phoneExt":29,"email":29},"Xiaohui Qiao",{"type":352,"investigatorFullName":182,"investigatorTitle":353,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Professor",[355],{"name":356,"class":357},"LinkDoc Technology (Beijing) Co. Ltd.","INDUSTRY","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":369,"type":370},402,"ESTIMATED","INTERVENTIONAL",[373],"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.",[376],"Nephrotic Syndrome in Children",[26,378,379],"Children","Nephrotic syndrome","2024-06-20",{"date":382,"type":383},"2024-06-21","ACTUAL",{"date":385,"type":383},"2023-04-26",{"date":387,"type":370},"2025-10-30",{"name":182,"class":6},26]