UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027976 |
|---|---|
| Receipt number | R000031487 |
| Scientific Title | Evaluation of the efficacy of yokukansan for postoperative delirium |
| Date of disclosure of the study information | 2017/07/03 |
| Last modified on | 2019/06/14 21:52:27 |
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Basic information
Public title
Evaluation of the efficacy of yokukansan for postoperative delirium
Acronym
Evaluation of the efficacy of yokukansan for postoperative delirium
Scientific Title
Evaluation of the efficacy of yokukansan for postoperative delirium
Scientific Title:Acronym
Evaluation of the efficacy of yokukansan for postoperative delirium
Region
| Japan |
Condition
Condition
postoperative delirium
Classification by specialty
| Psychosomatic Internal Medicine | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of yokukansan as preventive internal administration for post operative delirium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of delirium diagnosed using DSM-5 by psychiatrists on postoperative day 1,2, and 3
Key secondary outcomes
Severity of delirium by Delirium Rating Scale R-98
Safety (adverse events, laboratory values, postoperative complications, postoperative mortality)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Yokukansan group take 2.5 g of yokukansan before every meal from the morning of the previous day until the morning of the operation day. After surgery, patients start taking yokukansan as soon as possible and take until the 3rd postoperative day.
Interventions/Control_2
Control group take 2.5 g of anchusan before every meal from the morning of the previous day until the morning of the operation day. After surgery, patients start taking anchusan as soon as possible and take until the 3rd postoperative 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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who need surgery for gastrointestinal cancerPatients who can start oral administration early after surgery
Key exclusion criteria
Patients with past history of hypersensitivity to yokukansan or anchusan
Patients diagnosed with pseudoaldosteronism
Patients diagnosed with heart failure
Patients with a history of rhabdomyolysis
Patients diagnosed with interstitial pneumonia
Patients diagnosed with liver failure
Patients who cannot start oral administration early after surgery, such as esophageal cancer patients
Patients with mood disorder, schizophrenia, schizoaffective disorder, alcoholism, drug addiction
Patients determined to be unable to join the clinical trial
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Fujiwara |
Organization
Tottori University Hospital
Division name
Gastrointestinal surgery
Zip code
Address
36-1 Nishi-cho Yonago-shi
TEL
0859-38-6567
y-fujiwara@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akimitsu Tanio |
Organization
Tottori University Hospital
Division name
Gastrointestinal surgery
Zip code
Address
36-1 Nishi-cho Yonago-shi
TEL
0859-38-6567
Homepage URL
atanio@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tottori University Hospital
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
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 | 07 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2019 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031487
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
