UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004417 |
|---|---|
| Receipt number | R000005151 |
| Scientific Title | Examination of efficacy of yokukansan for postoperative delirium. |
| Date of disclosure of the study information | 2010/10/25 |
| Last modified on | 2015/04/21 07:20:49 |
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Basic information
Public title
Examination of efficacy of yokukansan for postoperative delirium.
Acronym
Examination of efficacy of yokukansan for postoperative delirium.
Scientific Title
Examination of efficacy of yokukansan for postoperative delirium.
Scientific Title:Acronym
Examination of efficacy of yokukansan for postoperative delirium.
Region
| Japan |
Condition
Condition
postoperative delirium
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination the effect of reducing the incidence of postoperative delirium by perioperative administration of yokukansan for eiderly patients with gastrointestinal cancer surgery at risk of postoperative delirium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CAM
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
yokukansan peroral administration, 7.5g/day, 3 times/day
Interventions/Control_2
none
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
1)Patients over 75 years
2) There is no gender specification
3) Patients who have signed consent to participate in this research.
Key exclusion criteria
1) Patients with malignancy, severe disease of heart, liver, renal, blood, lung and other life-threatening diseases
2) eurodegenerative disease, schizophrenia, bipolar disorder
3) Alcohol abuse, drug abuse
4) Patients who are otherwise classified as unfit by the attending physicians for the research.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Suzuki |
Organization
Nippon Medical School Musashi Kosugi
Hospital
Division name
Digestive Disease Center
Zip code
Address
1-396 Kosugi,Kawasaki,kanagawa 211-8533 JAPAN
TEL
044-733-5181
hide2808@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Nomura |
Organization
Nippon Medical School Musashi Kosugi
Division name
Digestive Disease Center
Zip code
Address
1-396 Kosugi,Kawasaki,kanagawa 211-8533 JAPAN
TEL
044-733-5181
Homepage URL
carlos10valderrama@yahoo.co.jp
Sponsor or person
Institute
Nippon Medical School Musashi Kosugi
Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanto Rosai hospital
Kawasaki Saiwai hospital
Teikyo University School Medicine Uniersity Hospital Mizonokuchi
Omori Red Cross Hospital
Kawasaki Municipal Hospital
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
| 2010 | Year | 10 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 20 | Day |
Last modified on
| 2015 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005151
