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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003955
Receipt No. R000004764
Scientific Title A randomized study of traditional Japanese medicine, yokukansan, in the treatment of delirium after hepatectomy
Date of disclosure of the study information 2010/09/01
Last modified on 2011/07/27

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Basic information
Public title A randomized study of traditional Japanese medicine, yokukansan, in the treatment of delirium after hepatectomy
Acronym Yokukansan in the treatment of delirium after hepatectomy
Scientific Title A randomized study of traditional Japanese medicine, yokukansan, in the treatment of delirium after hepatectomy
Scientific Title:Acronym Yokukansan in the treatment of delirium after hepatectomy
Region
Japan

Condition
Condition delirium
Classification by specialty
Geriatrics Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of yokukansan in the treatment of delirium
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes incidence of delirium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 prescribe yokukansan before and after hepatectomy
Interventions/Control_2 no prescription of yokukansan
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
100 years-old >
Gender Male
Key inclusion criteria patients plan to have hepatectomy
Key exclusion criteria history of delirium
emergency surgery
patients plan to have radiation
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Takechi
Organization Grduate School ofMedicine, Kyoto University
Division name Dept. of Geriatrics
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Takechi
Organization Grduate School ofMedicine, Kyoto University
Division name Dept. of Geriatrics
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
Homepage URL
Email

Sponsor
Institute Dept. of Geriatrics, Grduate School ofMedicine, Kyoto University
Institute
Department

Funding Source
Organization Scholarship for geriatric neurology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Dept. of Surgery, Kyoto University
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 京都大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2010 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
2012 Year 10 Month 01 Day
Date trial data considered complete
2012 Year 11 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 27 Day
Last modified on
2011 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004764

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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