NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000027561

Registered date:04/06/2017

Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery:a randomized, double-blind, placebo-controlled trial

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPreoperative anxiety and postoperative delirium
Date of first enrollment2017/08/14
Target sample size220
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)TJ-54 TSUMURA Yokukansan Extract Granules for Ethical Use Oral administration of Yokukansan (7.5g/day t.i.d. before meals) for at least 4 days before operation. Placebo granules. Oral administration of Placebo granules (7.5g/day t.i.d. before meals) for 4 days or over before operation

Outcome(s)

Primary Outcome1.Change in preoperative anxiety 2.Incidence rate of postoperative delirium
Secondary Outcome1.Severity of postoperative delirium (DRS-98-R) 2.Duration of postoperative delirium 3.Preoperative Benzodiazepine dose 4.Postoperative antipsychotic dose 5.Postoperative hospitalization days 6.Adverse events/reactions

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1.Drug abuse history including the stimulant drug 2.Delirium diagnosis with DSM-5 in registration 3.Kampo medication within 4 weeks ahead of registration 4.Medical history of serious drug allergy 5.Grade2 Hypokalemia or worse of CTCAE v4.0 within 8 weeks ahead of registration 6.Chemotherapy and/or radiotherapy planned within 1 week after surgery 7.Participation in other clinical trials, which use other medicine, within 3 months ahead of registration 8.Being judged as inadequate by physician

Related Information

Contact

public contact
Name Saho Wada
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Telephone 03-3542-2511
E-mail sawada@ncc.go.jp
Affiliation National Cancer Center Hospital Department of Psycho-Oncology
scientific contact
Name Ken Shimizu
Address 5-1-1, Tsukiji Chuo-ku, Tokyo, 104-0045 Japan
Telephone 03-3542-2511
E-mail keshimiz@ncc.go.jp
Affiliation National Cancer Center Hospital Department of Psycho-oncology