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

Not Applicable

• Conditions: Abdominal pain and abdominal fullness feeling in the patients with fecal incontinence

• Registration Number: JPRN-jRCTs061180031
• Lead Sponsor: Shimazutsu Kazufumi

Brief Summary

To be published in the paper.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-27
• Study Completion: 2019-03-04
• Results First Posted: 2022-01-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified