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A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy.

A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy. - A safety and efficacy exploratory study of daikenchuto to relieve abdominal bloating in patients who has been ileostomy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016531
Enrollment
10
Registered
2015-02-13
Start date
2015-02-16
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

Ileostomy patients with abdominal bloating

Interventions

Taking Daokenchuto 15g/day orally for 4 weeks.

Sponsors

Sapporo Higashi Tokushukai Hospital Center for Clinical and Biomedical Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who has been ileostomy 2)Patients with abdominal bloating 3)Age: more than or equal to 20 years at the time of providing informed consent 4)Patients are male or female 5)Patients are in patients or out patients 6)Patients have ileotoma. 7)Provide written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with strangulating intestinal obstruction. 2)Patients who are administrated preparation for viable organism within 4 weeks before this study. 3)Patients who was administrated daikenchuto or any Japanese traditional herbal medicine within 4 weeks before this study 4)Virus-positive (HIV, HBV, HCN) 5)Patients have serious coexisting disease (ex. Hepatic distorder, kidney disorder, cardiac disorder, hematological disorder, or metabolic disorder) 6)Women who was lactating or pregnant or person who hope the pregnancy of the partne. 7)Unsuitability as determined by the study doctor

Design outcomes

Primary

MeasureTime frame
1)Abdominal bloating 2)Gastrointestinal symptom rating scale(GSRS) 3)Analysis of ileostomy effluent -intestinal flora -organic acid -pH

Countries

Japan

Contacts

Public ContactToru Kono

Sapporo Higashi Tokushukai Hospital Center for Clinical and Biomedical Research

kono@toru-kono.com011-722-1110

Outcome results

None listed

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