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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003103

Enrollment

200

Registered

2010-02-01

Start date

2010-02-01

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

Primary or metastatic liver 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) PS(ECOG Performance Status Scale):0-2 2) Patients who is able to have oral intake of the test drugs 3) Age: 20 years or older 4) Gender: no specification 5) 4weeks or more blank after therapy is needed in case of receiving chemotherapy or radiotherapy in the prior treatment 6) Adequate organ functions and operable patient 7) CRP <= 2mg/dL 8) Inpatient/Outpatient: Inpatient(study duration) 9) Patients who can provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who are scheduled to undergo laparoscopic hepatectomy 2) Patients with history of hepatectomy 3) Patients with inflammatory bowel disease (ulcerative colitis, Crohn disease)(including anamnestic case) 4) Patients requiring emergency surgery 5) Patients with synchronous or metachronous gastric resection 6) Patients with synchronous colon resection 7) RFA in the remnant liver at the same time as excising hepatectomy 8) Patients with history of chemotherapy or radiotherapy within4weeks before surgery , history of perioperative chemotherapy or radiotherapy 9) Patients who are scheduled to undergo chemotherapy or radiotherapy within 10days after surgery 10) Patients who are administered another Kanpo medicines for medical treatment within 4weeks before the test drug administration 11) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy 12) Patients undergoing biliary reconstruction 13) Patients who have a colostomy 14) Patients with history of resection of digestive canal 15) Constitutional selective defect in the hepatic transport of indocyanine green (ICG) ;Patients who are ICG intolerant 16) Synbiotics combination 17) Others, patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

Measure	Time frame
1) Time to first defecation after nasogastric tube removal (hr) 2) Postoperative number of bowel movements per day 3) blood ammonia level(micro gram/dL) 4) CRP(mg/dL)	—

Secondary

Measure	Time frame
1) QOL assessment by the GSRS Score (Japanese Version) 2) ICG-R15(%) 3) Incidence of postoperative intestinal obstruction 4) Incidence of postoperative complications 5) postoperative length of stay	—

Countries

Japan

Outcome results

None listed

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