Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery (a randomized, double-blind, multi-center, placebo-controlled study) Additional study:Gastrointestinal transit time as an indicator

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001793

Enrollment

100

Registered

2009-03-24

Start date

2009-03-01

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

Colon cancer (Sigmoidal and Rectosigmoidal regions)

Interventions

A capsule of radiopaque markers is taken with test drug(Daikenchuto) orally at 8:00 a.m. on postoperative day 2. A capsule of radiopaque markers is taken with test drug(placebo) orally at 8:00 a.m. o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Participate in JFMC39-0902 2)Amenable to curative resection in colon cancer (Sigmoidal and Rectosigmoidal regions) 3)Patients who can provide written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

Measure	Time frame
Total number of elimination of the markers	—

Secondary

Measure	Time frame
1) Time to first flatus (hr) after nasogastric tube removal 2) Segmental transit time (gastric emptying, small intestinal transit, and colonic transit (right, left, and rectosigmoid colon))	—

Countries

Japan

Outcome results

None listed

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