JPRN-UMIN000003103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)
Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 200 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
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) PS(ECOG Performance Status Scale):0-2
- •2) Patients who is able to have oral intake of the test drugs
- •3) Age: 20 years or older
- •4) Gender: no specification
- •5) 4weeks or more blank after therapy is needed in case of receiving chemotherapy or radiotherapy in the prior treatment
- •6) Adequate organ functions and operable patient
- •7) CRP <= 2mg/dL
- •8) Inpatient/Outpatient: Inpatient(study duration)
- •9) Patients who can provide written informed consent
排除标准
- •1) Patients who are scheduled to undergo laparoscopic hepatectomy
- •2) Patients with history of hepatectomy
- •3) Patients with inflammatory bowel disease (ulcerative colitis, Crohn disease)(including anamnestic case)
- •4) Patients requiring emergency surgery
- •5) Patients with synchronous or metachronous gastric resection
- •6) Patients with synchronous colon resection
- •7) RFA in the remnant liver at the same time as excising hepatectomy
- •8) Patients with history of chemotherapy or radiotherapy within4weeks before surgery , history of perioperative chemotherapy or radiotherapy
- •9) Patients who are scheduled to undergo chemotherapy or radiotherapy within 10days after surgery
- •10) Patients who are administered another Kanpo medicines for medical treatment within 4weeks before the test drug administration
- •11) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
- •12) Patients undergoing biliary reconstruction
- •13) Patients who have a colostomy
- •14) Patients with history of resection of digestive canal
- •15) Constitutional selective defect in the hepatic transport of indocyanine green (ICG) ;Patients who are ICG intolerant
- •16) Synbiotics combination
- •17) Others, patients who are unfit for the study as determined by the attending physician
研究者
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