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

UMIN ID: UMIN000027561

Registered date:04/06/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Preoperative anxiety and postoperative delirium
• Date of first enrollment: 2017/08/14
• Target sample size: 220
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: 1.Change in preoperative anxiety 2.Incidence rate of postoperative delirium
• Secondary Outcome: 1.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 minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.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

• Primary Sponsor: National Cancer Center
• Source(s) of Monetary Support: TSUMURA & CO.