[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"irinotecan-induced-diarrhea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:irinotecan-induced-diarrhea":28},{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100520331","xcht-for-irinotecan-induced-gut-toxicities-randomized-controlled-trial-100520331",false,"NCT06055179","XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)","Mechanistic and Pharmacokinetic Studies of Classical Chinese Formula Xiao Chai Hu Tang (XCHT) Against Irinotecan-Induced Gut Toxicities(Clinical Study Part:Randomized Controlled Trial)","Inclusion criteria:\n\n1. Malignant tumor confirmed by histology or cytology;\n2. Age ≥ 18 years old, ≤ 75 years old;\n3. ECOG score of the patient ≤ 2 points;\n4. Patients who have diarrhea worse than grade 2 due to irinotecan chemotherapy (the last dose of irinotecan is administered within 1 month);\n5. Patients who plan to receive 3 cycles of irinotecan chemotherapy (the dose of irinotecan ≥ 125mg\u002Fm2);\n6. Normal organ functions which can meet the requirements for systemic chemotherapy:\n\n   * Normal bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, PLT ≥ 100×109\u002FL, hemoglobin ≥ 90g\u002FL;\n   * Normal renal functions: serum creatinine ≤ 1.5mg\u002Fdl (133μmol\u002FL) and\u002For creatinine clearance ≥ 60ml\u002Fmin;\n   * Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value (ULN), serum aspartate aminotransferase (AST) \\& alanine aminotransferase (ALT) ≤ 2.5× ULN; AST \\& ALT ≤ 5 × ULN if abnormal hepatic functions are caused by a potentially malignant tumor.\n7. Patients who can understand and complete the questionnaires in the case report form;\n8. Patients who can understand and sign the informed consent form, is well compliant, and can be followed up.\n\nExclusion Criteria:\n\n1. Patients with diagnosed depression, obsession or\u002Fand schizophrenia;\n2. Patients with diagnosed inflammatory bowel diseases (including Crohn's disease, ulcerative colitis)\n3. Patient with active tuberculosis and other uncontrolled infections;\n4. Patient who has previously received radiotherapy on the abdominal cavity or pelvic cavity;\n5. Pregnant or lactating women;\n6. Patient who previously had or is now having thromboembolic events.","ALL","18 Years","75 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24],"NA","Randomized double-blind placebo-controlled trial (RCT) study, to determine the impact of XCHT on irinotecan-induced severe delayed-onset diarrhea (SDOD), and to determine the feasibility of using plasma raloxifene-4'-glucuronide as a probe for intestinal UGT activity.",[27,28],"Xiao Chai Hu Tang","Irinotecan-induced Diarrhea",[30,31,27,32,33],"Malignant tumor","Irinotecan-induced diarrhea","Classical Chinese Formula","pharmacokinetic mechanism","RECRUITING","2025-06-29",{"date":37,"type":38},"2025-07-01","ACTUAL",{"date":40,"type":38},"2024-03-08",{"date":42,"type":21},"2026-12-01",{"name":44,"class":45},"Guangzhou University of Traditional Chinese Medicine","OTHER"]