UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Title of the study (Brief title)	Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Region	Japan

Condition
Condition	Gastrointestinal cancer Lung cancer
Classification by specialty	Surgery in general Gastrointestinal surgery Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine the effect of the yokukansan ,which is administered before and after the surgery, in prevention of the delirium after the surgical operation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of delirium after the operation safety
Key secondary outcomes	Hospital days after the operation Severity of symptoms of delirium

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Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	yokukansan administering group
Interventions/Control_2	yokukansan non-administering group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients undergoing elective surgery for gastrointestinal cancer or lung cancer. 2)Patients aged over 70. 3)ECOG Performance status is 0 to 2 4)Patient who is not scheduled to enter ICU after the operation. 5)Major organ function is preserved. 6)Witten informed consent is taken.
Key exclusion criteria	1)Prior therapy with major tranquilizer within the past 6 months. 2)Serious complications due to psychological illness. 3)Uncontrollable heart disease. 4)Chronic renal failure or renal disfunction(Cr>=1.5 mg/dl). 5)Patients judged to be inappropriate by doctor in charge.
Target sample size	220

Research contact person
Name of lead principal investigator	Yasushi Rino
Organization	Yokohama City University
Division name	general surgery
Address	3-9Fukuura,Kanazawa-ku,Yokohama City,236-0004,Japan
TEL	045-787-2645
Email	rino@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Nobuhiro Sugano
Organization	Yokohama City University
Division name	general surgery
Address	3-9Fukuura,Kanazawa-ku,Yokohama City,236-0004,Japan
TEL	045-261-5656
Homepage URL
Email	suga_p1012@yahoo.co.jp

Sponsor
Institute	Department of surgery,yokohama city university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	神奈川県立足柄上病院（神奈川県） 国際医療福祉大学　熱海病院（静岡県） 国家公務員共済組合連合会　平塚共済病院（神奈川県） 国家公務員共済組合連合会　南共済病院（神奈川県） 国家公務員共済組合連合会　横須賀共済病院（神奈川県） 総合病院　秦野赤十字病院（神奈川県） 藤沢湘南台病院　（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 12 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2011 Year 04 Month 12 Day
Last modified on	2016 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006439