UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy of yokukansan for postoperative delirium
Acronym	Evaluation of the efficacy of yokukansan for postoperative delirium
Scientific Title	Evaluation of the efficacy of yokukansan for postoperative delirium
Scientific Title:Acronym	Evaluation of the efficacy of yokukansan for postoperative delirium
Region	Japan

Condition
Condition	postoperative delirium
Classification by specialty	Psychosomatic Internal Medicine Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of yokukansan as preventive internal administration for post operative delirium
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rate of delirium diagnosed using DSM-5 by psychiatrists on postoperative day 1,2, and 3
Key secondary outcomes	Severity of delirium by Delirium Rating Scale R-98 Safety (adverse events, laboratory values, postoperative complications, postoperative mortality)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Yokukansan group take 2.5 g of yokukansan before every meal from the morning of the previous day until the morning of the operation day. After surgery, patients start taking yokukansan as soon as possible and take until the 3rd postoperative day.
Interventions/Control_2	Control group take 2.5 g of anchusan before every meal from the morning of the previous day until the morning of the operation day. After surgery, patients start taking anchusan as soon as possible and take until the 3rd postoperative day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who need surgery for gastrointestinal cancerPatients who can start oral administration early after surgery
Key exclusion criteria	Patients with past history of hypersensitivity to yokukansan or anchusan Patients diagnosed with pseudoaldosteronism Patients diagnosed with heart failure Patients with a history of rhabdomyolysis Patients diagnosed with interstitial pneumonia Patients diagnosed with liver failure Patients who cannot start oral administration early after surgery, such as esophageal cancer patients Patients with mood disorder, schizophrenia, schizoaffective disorder, alcoholism, drug addiction Patients determined to be unable to join the clinical trial
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiyuki Fujiwara
Organization	Tottori University Hospital
Division name	Gastrointestinal surgery
Zip code
Address	36-1 Nishi-cho Yonago-shi
TEL	0859-38-6567
Email	y-fujiwara@med.tottori-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akimitsu Tanio
Organization	Tottori University Hospital
Division name	Gastrointestinal surgery
Zip code
Address	36-1 Nishi-cho Yonago-shi
TEL	0859-38-6567
Homepage URL
Email	atanio@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University Hospital
Institute
Department

Funding Source
Organization	Tottori University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 05 Month 22 Day
Date of IRB	2017 Year 04 Month 25 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 28 Day
Last modified on	2019 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031487