Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy (a randomized, double-blind, multi-center, placebo-controlled study)

Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy (a randomized, double-blind, multi-center, placebo-controlled study) - Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy (a randomized, double-blind, multi-center, placebo-controlled study) (JFMC42-1002)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004693

Enrollment

240

Registered

2011-01-01

Start date

2011-01-01

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

Gastric cancer

Interventions

Oral administration of test drug (Daikenchuto) 5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before meals. Oral administration of test drug (placebo)5.0g per dose as a general rule (2.5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Clinical Stage: IA-IIIA 2) Open abdominal operation 3) Reconstruction : Roux-en-Y 4) PS(ECOG Performance Status Scale) : 0-1 5) Age: 20 years or older, under 85 years 6) Gender: no specification 7) Inpatient/Outpatient: Inpatient(study duration) 8) Patients who can provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with history of chemotherapy or within 4weeks before surgery or scheduled to undergo chemotherapy during the test drug administration 2) Perioperative radiotherapy 3) Patients with history of radiotherapy to the abdomen 4) Patiens scheculed to be under postoperative artificial respiration after surgery 5) Patients with inflammatory bowel disease (ulcerative colitis, Crohn disease)(including anamnestic case) 6) Patients requiring emergency surgery 7) Patients with multiple cancer 8) Patients with peritoneum metastasis 9) Patients with synchronous colon resection 10) Insuufficient organ functions 11) Patients with history of colon resections 12) Patients with history of laparotomy and peritonitis (excludeing surgery for appendicitis) 13) Patients who are administered another Kampo medicines for medical treatment within 4weeks before the test drug administration 14) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy 15) Others, patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

Measure	Time frame
1) Time to first flatus and defecation after nasogastric tube removal (hr) 2) Number of bowel movements per day after operation	—

Secondary

Measure	Time frame
1) QOL assessment by the GSRS Score(Japanese Version) and FACT-Ga Score 2) CRP(mg/dL) 3) Incidence of postoperative intestinal dysmotility 4) Incidence of postoperative ileus	—

Countries

Japan

Outcome results

None listed

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