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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030252

Enrollment

Registered

2017-12-11

Start date

2017-12-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Daikenchuto (15g/day) for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who have faecal incontinence of 2-4 times/4 weeks or more in the past 6 months 2)Patients who have abdominal pain or abdominal fullness feeling 3)Age: Aged 20 and over 4)Mini Mental State Examination (MMSE)>=11 5)Patients for whom oral administration was possible 6)Patients who provided written informed consent regarding study participation.

Exclusion criteria

Exclusion criteria: 1)Patients who have anal sphincter injury 2)Patients who have severe mental illness 3)Patients who can not perform their daily activities 4)Suspected organic disease such as the cancer in gastrointestinal tract 5)Presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease) 6)Patients who took drugs prohibited for concomitant use 2 weeks before entry. 7)History of allergic reactions to Kampo medicines 8)Pregnant or lactating women or those who are planning to conceive during the study period 9)Considered ineligible to participate by principal investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
1) Numeric Rating Scale (NRS) of abdominal pain 2) NRS of abdominal fullness feeling	—

Countries

Japan

Contacts

Public ContactKazufumi Shimazutsu

Medical Corporation Seiaikai, Gion Ushita Hospital Gion Ushita Hospital

stratmagic@mac.com082-850-3116

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026