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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027475
Receipt No. R000031475
Scientific Title Examination of efficacy of yokukansan for post operative delirium
Date of disclosure of the study information 2017/08/20
Last modified on 2017/06/07

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Basic information
Public title Examination of efficacy of yokukansan for post operative delirium
Acronym Examination of efficacy of yokukansan for post operative delirium
Scientific Title Examination of efficacy of yokukansan for post operative delirium
Scientific Title:Acronym Examination of efficacy of yokukansan for post operative delirium
Region
Japan

Condition
Condition post operative delirium
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefullness of TJ-54 for post-operative delirium in digestive cancer surgery in elderly patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of post operative delirium
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 Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients undergoing elective surgery for gastrointestinal cancer
2)Patients aged over 70
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 , lung or liver diseases , or , with other complications judged to be life-theatening
3)Serious complications due to psychological illness
4)Other Kampo medicine
5)patients who were judged to be inappropriate as subjects by the study investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kanda
Organization Juntendo University
Division name Gatoroenterology and Minimally invasive surgery
Zip code
Address 3-1-3 Hongo , Bunkyoku , Tokyo , Japan
TEL 03-3813-3111
Email sat-kanda@rapid.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Kanda
Organization Juntendo University
Division name Gatoroenterology and Minimally invasive surgery
Zip code
Address 3-1-3 Hongo , Bunkyoku , Tokyo , Japan
TEL 03-3813-3111
Homepage URL
Email sat-kanda@rapid.ocn.ne.jp

Sponsor
Institute Juntendo University
Gastroenterology and minimally invasive surgery
Institute
Department

Funding Source
Organization Not appricable
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 08 Month 20 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
2017 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 24 Day
Last modified on
2017 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031475

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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