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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005423
Receipt No. R000006439
Scientific Title Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Date of disclosure of the study information 2011/04/12
Last modified on 2016/06/01

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Basic information
Public title Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Acronym Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Scientific Title Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Yasushi Rino
Organization Yokohama City University
Division name general surgery
Zip code
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
1st name
Middle name
Last name Nobuhiro Sugano
Organization Yokohama City University
Division name general surgery
Zip code
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

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)

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 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

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 Completed
Date of protocol fixation
2011 Year 04 Month 12 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000006439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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