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临床试验/JPRN-jRCTs061180031
JPRN-jRCTs061180031已完成未知

The exploratory study for the efficacy and the safety of Daikenchuto(TJ-100) on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.

Shimazutsu Kazufumi0 个研究点目标入组 21 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
21

研究概览

简要总结

To be published in the paper.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

入选标准

  • Patients who have faecal incontinence of 2-4 times/4 weeks or more in the past 6 months
  • Patients who have abdominal pain or abdominal fullness feeling
  • Age: Aged 20 and over
  • Mini Mental State Examination (MMSE) over 11
  • Patients for whom oral administration was possible
  • Patients who provided written informed consent regarding study participation

排除标准

  • Patients who have anal sphincter injury
  • Patients who have severe mental illness
  • Patients who can not perform their daily activities
  • Suspected organic disease such as the cancer in gastrointestinal tract
  • Presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease)
  • Patients who took drugs prohibited for concomitant use 2 weeks before entry.
  • History of allergic reactions to Kampo medicines
  • Pregnant or lactating women or those who are planning to conceive during the study period
  • Considered ineligible to participate by principal investigator or sub-investigator

研究者

发起方
Shimazutsu Kazufumi

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