UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	A clinical study of yokukansan in patients with postoperative delirium after surgical resection of malignant tumor of digestive system.
Region	Japan

Condition
Condition	Digestive system cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the inhibition effect and safety of yokukansan for onset of postoperative delirium in elderly.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of postoperative delirium
Key secondary outcomes	Postoperative length of stay in the hospital Severity of symptoms of delirium Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	yokukansan administering group(7.5mg/day)
Interventions/Control_2	yokukansan non-administering group (0mg/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	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
Key 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
Target sample size	40

Research contact person
Name of lead principal investigator	Tsunehiko Maruyama
Organization	Hitachi,Ltd.,Hitachi General Hospital
Division name	Surgery
Address	2-1-1,Jonann-cho,Hitachi-si,Ibaraki-Ken,Japan
TEL	0294-23-1111
Email	tsunehiko.maruyama.kq@hitachi.com

Public contact
Name of contact person	Masayo Okawa
Organization	Hitachi,Ltd.,Hitachi General Hospital
Division name	clinical research center
Address	2-1-1,Jonann-cho,Hitachi-si,Ibaraki-Ken,Japan
TEL	0294-23-1111
Homepage URL
Email	masayo.okawa.ne@hitachi.com

Sponsor
Institute	Hitachi,Ltd.,Hitachi General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	株式会社日立製作所　日立総合病院(茨城県）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 18 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 24 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015379