UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003955 |
|---|---|
| Receipt number | 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 | 2024/02/05 13:30:01 |
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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 | Hajime |
| Middle name | |
| Last name | Takechi |
Organization
Grduate School ofMedicine, Kyoto University
Division name
Dept. of Geriatrics
Zip code
606-8397
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513111
takechi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Takechi |
Organization
Grduate School ofMedicine, Kyoto University
Division name
Dept. of Geriatrics
Zip code
606-8397
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513111
Homepage URL
takechi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Dept. of Geriatrics, Grduate School ofMedicine, Kyoto University
Institute
Department
Personal name
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
Kyoto- University
Address
Sakyo-ku, Kyoto
Tel
0757513111
takechi@kuhp.kyoto-u.ac.jp
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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 01 | Day |
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
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004764
