[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-radiation-proctitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-radiation-proctitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100580461","phase-3-jianzhong-qushi-in-chronic-rri-100580461",false,"NCT06837597","Jianzhong Qushi in Chronic RRI","Jianzhong Qushi Formula for Treating Chronic Radiation Induced Proctitis : a Multicenter, Prospective, Randomized Controlled Clinical Trial","ACRON","Inclusion Criteria:\n\n* Age 18 - 85 years old\n* ECOG score ≤ 2\n* Pathologically confirmed malignant tumor\n* Received pelvic radiotherapy, and it has been ≥ 3 months since the end of radiotherapy ;\n* Meet the diagnostic criteria for chronic radiation proctitis in the \"2023 Edition of the Practice Guidelines for the Prevention and Treatment of Radiation Proctitis\" or the \"2023 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Intestinal Injury in Traditional Chinese and Western Medicine in China\", with an international grading of level 1 - 2\n* Meet the syndrome of spleen deficiency , and the syndrome differentiation is determined according to the \"2017 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis (Intestinal Syndrome) in Traditional Chinese Medicine\" formulated by the Oncology Branch of the China Association of Traditional Chinese Medicine : Basic Syndrome PRO Scale of Spleen Deficiency (meeting 2 main symptoms or 1 main symptom\\* + 2 secondary symptoms#).\n* Hemoglobin ≥ 100 g \u002F L, neutrophils ≥ 1.5 × 10\\^9\\^ \u002F L\n* Serum creatinine ≤ 1.25 times the upper normal limit (UNL)\n* Total bilirubin ≤ 1.5 times UNL, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times UNL\n* The patient has signed the informed consent form\n* The patient agrees to cooperate with the follow - up. \\*Main symptoms included abdominal distension ,anorexia,tenesmus, unsatisfactory bowel movement and fatigue.\n\n  * Secondary symptoms included spontaneous sweating, dizziness,feeling of heaviness in the head, feeling of heaviness in the body, nausea and palpitations.\n\nExclusion Criteria:\n\n* Other causes of enteritis cannot be ruled out\n* The relevant symptoms existed before radiotherapy and did not worsen after treatment\n* Allergy to more than 3 components of the Western medicine used in this study or the formula of Jianzhong Qushi Formula\n* Tumor progression requiring urgent anti-tumor treatment\n* Urgent surgical or endoscopic treatment is needed\n* Has already entered other clinical studies targeting RRI\n* Nursing or pregnant women\n* Those who may interfere with the study evaluation.","ALL","18 Years","85 Years",{"count":21,"type":22},168,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is a multicenter, randomized, double-blind, placebo-controlled trial. Patients diagnosed as CRP and without TCM history will be enrolled and randomly assigned to either the treatment group (receiving standard care plus Jianzhong Qushi Formula, 100 ml bid, \\*28days) or the control group (receiving standard care plus placebo 100 ml bid, \\*28days). All of the patients received both The primary endpoint is the clinical response rate, defined as fulfilling one of the following, RTOG grade reduction, ① RTOG\u002FEORTC grade reduction; ② ≥1 symptom downgraded by CTCAE v5.0; ③ Symptom improvement according to TCM symptom standards .The secondary endpoints included TCM syndrome score reduction rate, LENT\u002FSOMA score changes, changes in gut microbiota, quality of life(QoL) , etc. Totally, 168 patients (84 in each group) will be enrolled.",[28],"Chronic Radiation Proctitis",[30,28],"Chinese Tradiational Medicine","NOT_YET_RECRUITING","2025-02-25",{"date":34,"type":35},"2025-02-27","ACTUAL",{"date":37,"type":22},"2025-03-15",{"date":39,"type":22},"2029-01-31",{"name":41,"class":42},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100549804","phase-1-umbilical-cord-derived-mesenchymal-stem-cells-injection-for-chronic-radiation-proctitis-100549804","NCT06438809","Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis","Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis","Inclusion Criteria:\n\n1. Fully understand and sign the informed consent form;\n2. Age ≥18 years and \\\u003C80 years;\n3. Good physical condition (WHO performance status score 0-1);\n4. Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;\n5. Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;\n6. Screening period LENT-SOMA score ≥1;\n7. Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.\n\nExclusion Criteria:\n\n1. Patients with severe liver or kidney dysfunction during the screening period;\n2. Patients with severe congestive heart failure or coronary artery disease during the screening period;\n3. Patients with allergic constitution or severe systemic immune diseases;\n4. Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;\n5. Pregnant patients;\n6. Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;\n7. Patients with a screening period LENT-SOMA score of 4;\n8. Patients with tumor recurrence or metastasis;\n9. Patients currently participating in other clinical trials at the time of screening or who have not been out of another clinical trial for less than 1 month;\n10. Other situations deemed unsuitable for inclusion in this study by the investigator.","79 Years",{"count":52,"type":22},24,[54,55],"PHASE1","PHASE2","A Phase I\u002FII study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.",[28],"RECRUITING","2024-06-20",{"date":61,"type":35},"2024-06-21",{"date":63,"type":35},"2024-05-24",{"date":65,"type":22},"2025-05",{"name":67,"class":68},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY",1]