Exploratory study of clinical effectiveness and safety of daikenchuto (TJ-100) for gastrointestinal symptoms such as abdominal pain and distention following laparoscopic colectomy in colon cancer patients

Department of gastrointestinal surgery, Kyoto University0 个研究点目标入组 40 人开始时间: 2016年8月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•In order to participate in this study, a patient must meet all of the following criteria.
•1) Patients who qualify for curative resection for colon cancer.
•Preoperative TNM category distribution: T=1a-3, N=0-2,M=0
•2) Patients who suffer from abdominal pain and distention on postoperative day 1.
•3)PS (ECOG Performance Status Scale): 0-2
•4) Age: over 20 yo.
•5) Gender: no specification
•6) Inpatient/Outpatient: Inpatient
•7) Patients who can orally take Daikenchuto
•8) Patients who can provide written informed

•1) Patients who can orally take Daikenchuto on postoperative day 1.
•2) Patients with history of laparotomy
•3) Patients with history of ileum.
•4) Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease.
•5) Patients with concomitant endometriosis
•6) Patients requiring emergency surgery
•7) Patients who have been treated or will be treated by chemotherapy or radiotherapy for primary disease
•8) Patients with serious concomitant diseases
•9) Patients who took prohibited concomitant drugs 4 weeks before treatment.
•10) Patients with history of allergy for other Kampo
•formulation(s)
•11) Patients with infection of HBV or HCV
•12) Others, including patients who are unfit for the study as determined by the attending physician

发起方

Department of gastrointestinal surgery, Kyoto University