Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal symptoms in patients with history of colorectal cancer surgery; crossover study - Gastrointestinal transit time as an indicator -

Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal symptoms in patients with history of colorectal cancer surgery; crossover study - Gastrointestinal transit time as an indicator - - Clinical efficacy of Daikenchuto for gastrointestinal symptoms in patients with history of colorectal cancer surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007388

Enrollment

Registered

2012-04-01

Start date

2011-12-01

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

Gastrointestinal symptom (disorder of defecation, abdominal bloating) after colorectal cancer surgery

Interventions

A group: Oral administration of Daikenchuto (15g/day t.i.d. before meals) for 28 days. Thereafter non-treatment for 28 days. B group: Non-treatment for 28 days. Thereafter oral administration of Daike

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with history of colorectal cancer surgery before 6 months or more 2) Patients who diagnosed having digestive symptoms (disorder of defecation, abdominal bloating) and required medical treatment as a result of medical examination 3) Relapse-free patients 4) Patients who can orally administration of Daikenchuto 5) Age: over 20 yo. 6) Gender: no specification 7) Outpatient 8) Patients who can provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who have treated by chemotherapy or radiotherapy for primary disease 2) Patients with concomitant inflammatory bowel disease (ulcerative colitis, Crohn's disease) 3) Patients with double cancer (abdominal malignancy) 4) Patients with serious concomitant 5) Patients with serious drug allergy 6) Patients with galactosemia 7) Patients who have taken antibiotics within 4 weeks prior to study examination 8) Patients who are taking other Kampo formulation(s) 9) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy 10) Others, including patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

Measure	Time frame
1)total number of elimination of the radiopaque markers 2) oro-cecal transit time 3) GSRS (Japanese Version) Score 4) VAS 5) GVS	—

Secondary

Measure	Time frame
1) segmental transit time(gastric emptying, small intestinal transit, and colonic transit (right, left, and rectosigmoid colon)) 2) safety	—

Countries

Japan

Contacts

Public ContactHaruki Sada

Graduate school of biomedical sciences, Hiroshima university Department of surgery, division of frontier medical science, programs for biomedical research

z011028sangyo@yahoo.co.jp0822575222

Outcome results

None listed

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