An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system.

An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system. - A clinical study of yokukansan in patients with postoperative delirium after surgical resection of malignant tumor of digestive system.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013235

Enrollment

Registered

2014-02-26

Start date

2013-07-01

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

Digestive system cancer

Interventions

yokukansan administering group(7.5mg/day) yokukansan non-administering group (0mg/day)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who scheduled surgical resection of malignant tumor of digestive system. 2) Patients who can be administered drugs orally. 3) Patients who give written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1) Patients who require emergency surgery. 2)Patients with severe complications, including cardiac, renal, blood or lung diseases, or with other complications judged to be life-threatening. 3)Patients administered antipsychotic agents and therapeutic agents for dementia. 4)Patients administered Kampo medicines other than the study drug. 5) Patients who were judged to be inappropriate as subjects by the study investigators

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative delirium	—

Secondary

Measure	Time frame
Postoperative length of stay in the hospital Severity of symptoms of delirium Safety	—

Countries

Japan

Contacts

Public ContactMasayo Okawa

Hitachi,Ltd.,Hitachi General Hospital clinical research center

masayo.okawa.ne@hitachi.com0294-23-1111

Outcome results

None listed

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