JPRN-UMIN000001592已完成3 期
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery(a randomized, double-blind, multi-center, placebo-controlled study)
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 400 人开始时间: 2009年1月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who qualify for curative colonic resection (solely via laparotomy) for colon cancer (including rectosigmoidal region)
- •Preoperative staging of disease: I, II, IIIa, IIIb
- •TNM category distribution: T=1-3, N=0-2, M=0
- •2) PS (ECOG Performance Status Scale): 0, 1
- •3) Patients who can orally administration of Daikenchuto
- •4) Age: over 20 yo.
- •5) Gender: no specification
- •6) Inpatient/Outpatient: Inpatient
- •7) Patients who can provide written informed consent
排除标准
- •1) Patients with a history of endoscopic surgery
- •2) Patients with a history of laparoscopic surgery
- •3) Patients with concomitant inflammatory bowel disease (ulcerative colitis, Crohn disease)
- •4) Patients requiring emergency surgery
- •5) Patients with double cancer
- •6) Patients with serious liver disorder
- •7) Patients with serious renal disorder
- •8) Patients with history of laparotomy and peritonitis (excludes surgery for appendicitis)
- •9) Patients who are taking other Kampo formulation(s)
- •10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
- •11) Others, including patients who are unfit for the study as determined by the attending physician
研究者
相似试验
已完成
3 期
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery (a randomized, double-blind, multi-center, placebo-controlled study) Additional study:Gastrointestinal transit time as an indicatorColon cancer (Sigmoidal and Rectosigmoidal regions)JPRN-UMIN000001793Japanese Foundation for Multidisciplinary Treatment of Cancer100
已完成
不适用
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal symptoms in patients with history of colorectal cancer surgery; crossover study - Gastrointestinal transit time as an indicatorGastrointestinal symptom (disorder of defecation, abdominal bloating) after colorectal cancer surgeryJPRN-UMIN000007388Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university30
已完成
3 期
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy (a randomized, double-blind, multi-center, placebo-controlled study)Gastric cancerJPRN-UMIN000004693Japanese Foundation for Multidisciplinary Treatment of Cancer240
已完成
3 期
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following resection of liver cancer(a randomized, double-blind, multi-center, placebo-controlled study)Primary or metastatic liver cancerJPRN-UMIN000003103Japanese Foundation for Multidisciplinary Treatment of Cancer200
已完成
不适用
Clinical effectiveness of Daikenchuto (DKT: TJ-100) for abdominal pain or distention in perioperative period of pancreaticoduodenectomyPatients with pancreatic head tumors undergoing pancreaticoduodenectomyJPRN-UMIN000005056Wakayama Medical University1