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

JRCT ID: jRCTs061180031

Registered date:27/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Abdominal pain and abdominal fullness feeling in the patients with fecal incontinence
• Date of first enrollment: 09/12/2017
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Daikenchuto (15g/day) for 4 weeks

Outcome(s)

• Primary Outcome: Abdominal pain and abdominal fullness feeling

Secondary Outcome

the severity of fecal incontinence (Wexner score, Japanese version)
QOL of fecal incontinence (Fecal incontinence quality of life scales, Japanese version)
anorectal manometry (resting period or contracting period)
number of fecal incontinence, number of defecation
stool form (Bristol Stool Form Scale)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shimazutsu Kazufumi
• Source(s) of Monetary Support: Tsumura & Co.
• Secondary ID(s): UMIN000030252