[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456916":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":53,"locations":59,"responsibleParty":131,"collaborators":11,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":11,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":11,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":159,"whyStopped":11,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Yiqi Wenyang Jiedu prescription Group","EXPERIMENTAL",null,[13],"Drug: Yiqi Wenyang Jiedu prescription",{"label":15,"type":16,"description":11,"interventionNames":17},"Simulation agent of Yiqi Wenyang Jiedu prescription Group","PLACEBO_COMPARATOR",[18],"Drug: Simulation agent of Yiqi Wenyang Jiedu prescription",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Yiqi Wenyang Jiedu prescription","The dosage form of the test drug is granule. Patients need to take 2 small packets in the morning and 2 small packets in the evening. The medicine needs to be melted in hot water before being taken. Every 4 weeks is a course of treatment, a total of 6 courses,The patients were followed up to 3 years after gastric cancer surgery.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Simulation agent of Yiqi Wenyang Jiedu prescription","It is prepared from maltodextrin and food coloring. The raw materials of maltodextrin conform to the relevant provisions of excipients - maltodextrin in the fourth part of Chinese Pharmacopoeia 2015 edition. Food coloring includes caramel coloring, egg yolk coloring and milk chocolate brown pigment, all of which are edible grade ingredients. Patients need to take 2 small packets in the morning and 2 small packets in the evening. The medicine needs to be melted in hot water before being taken. Every 4 weeks is a course of treatment, a total of 6 courses,The patients were followed up to 3 years after gastric cancer surgery.",[15],[30,34,38,41,44,47,50],{"name":31,"affiliation":32,"role":33},"Jie Li, Professor","Guang 'anmen Hospital, China Academy of Chinese Medical Sciences","STUDY_DIRECTOR",{"name":35,"affiliation":36,"role":37},"Yu Wu, Professor","Xiyuan Hospital of China Academy of Chinese Medical Sciences","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Shijie Zhu, Professor","Wangjing Hospital, China Academy of Chinese Medical Sciences",{"name":42,"affiliation":43,"role":37},"Hong Zhao, Professor","Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"name":45,"affiliation":46,"role":37},"Lizhu Lin, Professor","The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine",{"name":48,"affiliation":49,"role":37},"Ling Xu, Professor","Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine",{"name":51,"affiliation":52,"role":37},"Peng Shu, Professor","Jiangsu Hospital of Traditional Chinese Medicine",[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Guanghui Zhu, Doctor","CONTACT","+86 13315714979","zhugh0822@163.com",[60,77,86,94,107,119],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":69,"coordinates":70},"Point",[71,72],116.39723,39.9075,{"lat":72,"lon":71},[75],{"name":76,"role":56,"phone":11,"phoneExt":11,"email":11},"Hong Zhao",{"facility":78,"status":62,"city":63,"state":64,"zip":79,"country":66,"countryCode":67,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"Xiyuan Hospital, China Academy of Chinese Medical Sciences","100091",{"type":69,"coordinates":81},[71,72],{"lat":72,"lon":71},[84],{"name":85,"role":56,"phone":11,"phoneExt":11,"email":11},"Yu Wu",{"facility":40,"status":62,"city":63,"state":64,"zip":87,"country":66,"countryCode":67,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"100102",{"type":69,"coordinates":89},[71,72],{"lat":72,"lon":71},[92],{"name":93,"role":56,"phone":11,"phoneExt":11,"email":11},"Shijie Zhu",{"facility":95,"status":62,"city":96,"state":97,"zip":98,"country":66,"countryCode":67,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"The First Affiliated Hospital of Guangzhou University of Chinese Medicine","Guangzhou","Guangdong","510405",{"type":69,"coordinates":100},[101,102],113.25,23.11667,{"lat":102,"lon":101},[105],{"name":106,"role":56,"phone":11,"phoneExt":11,"email":11},"Lizhu Lin",{"facility":52,"status":62,"city":108,"state":109,"zip":110,"country":66,"countryCode":67,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Nanjing","Jiangsu","210004",{"type":69,"coordinates":112},[113,114],118.77778,32.06167,{"lat":114,"lon":113},[117],{"name":118,"role":56,"phone":11,"phoneExt":11,"email":11},"Peng Shu",{"facility":49,"status":62,"city":120,"state":121,"zip":122,"country":66,"countryCode":67,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Shanghai","Shanghai Municipality","200437",{"type":69,"coordinates":124},[125,126],121.45806,31.22222,{"lat":126,"lon":125},[129],{"name":130,"role":56,"phone":11,"phoneExt":11,"email":11},"Ling Xu",{"type":132,"investigatorFullName":133,"investigatorTitle":134,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Jie Li","Assistant Dean","100456916","phase-4-clinical-trial-of-yiqi-wenyang-jiedu-prescription-in-the-prevention-and-treatment-of-postoperative-metastasis-and-recurrence-of-gastric-cancer-100456916",false,"NCT05229809","Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer","Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study","Inclusion Criteria:\n\n1. The non-esophagogastric junction gastric cancer of stage II-III that met the diagnostic criteria, and no tumor recurrence and metastasis was determined by imaging;\n2. Within 6-8 months after radical gastrectomy for gastric cancer (R0), adjuvant chemotherapy of standard regimen (XELOX and SOX) has been completed for at least 6 cycles;\n3. ECOG score 0-2;\n4. 18-75 years old, male or female;\n5. The expected survival time is ≥3 months;\n6. Voluntary participation in the study, signing informed consent, good compliance with follow-up.\n\nExclusion Criteria:\n\n1. Patients with other primary tumors;\n2. Gastric cancer patients were pathologically diagnosed as adenosquamous carcinoma, with lymphoid stromal carcinoma (medullary carcinoma), hepatoid adenocarcinoma, squamous cell carcinoma, signed-ring cell carcinoma, undifferentiated carcinoma, gastric neuroendocrine tumor, gastric mesenchymal tumor, gastric malignant lymphoma and other gastric malignancies;\n3. Patients who had previously received preoperative neoadjuvant chemotherapy;\n4. Patients with past or current targeted drug therapy;\n5. Patients undergoing previous or ongoing gastric radiotherapy;\n6. Patients with past or ongoing tumor immunotherapy;\n7. Mental patients;\n8. Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy;\n9. Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months;\n10. Patients who are known to be allergic or intolerant to the study drug.","ALL","18 Years","75 Years",{"count":146,"type":147},212,"ESTIMATED","INTERVENTIONAL",[150],"PHASE4","The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.",[153],"Gastric Carcinoma",[155,22,156,157,158],"Postoperative gastric cancer","Chinese Herbal Medicine","Randomized Controlled Trial","2-year disease-free survival rate","UNKNOWN","2022-10-31",{"date":162,"type":163},"2022-11-02","ACTUAL",{"date":165,"type":163},"2022-03-01",{"date":167,"type":147},"2024-07-31",{"name":133,"class":6},6]