UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050029 |
|---|---|
| Receipt number | R000056994 |
| Scientific Title | Efficacy and safety of TJ-54 (Yokukansan) for post-operative delirium, psychiatric symptoms, and pain: systematic review and meta-analysis. |
| Date of disclosure of the study information | 2023/01/13 |
| Last modified on | 2023/04/29 05:51:39 |
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Basic information
Public title
Efficacy and safety of TJ-54 (Yokukansan) for post-operative delirium, psychiatric symptoms, and pain: systematic review and meta-analysis.
Acronym
Efficacy and safety of TJ-54 (Yokukansan) for post-operative delirium, psychiatric symptoms, and pain: systematic review and meta-analysis.
Scientific Title
Efficacy and safety of TJ-54 (Yokukansan) for post-operative delirium, psychiatric symptoms, and pain: systematic review and meta-analysis.
Scientific Title:Acronym
Efficacy and safety of TJ-54 (Yokukansan) for post-operative delirium, psychiatric symptoms, and pain: systematic review and meta-analysis.
Region
| Japan |
Condition
Condition
Post-operative patients treated with TJ-54 (Yokukansan)
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the efficacy and safety of TJ-54(Yokukansan) for post-operative delirium, psychiatric symptoms, and pain
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the efficacy of TJ-54(Yokukansan) for post-operative delirium, psychiatric symptoms, and pain
Key secondary outcomes
the safety of TJ-54(Yokukansan) for post-operative delirium, psychiatric symptoms, and pain
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
PICO
Patients: post-operative patients
Intervention: use of TJ-54 (Yokukansan)
Comparison: no use of TJ-54 (Yokukansan) or placebo
Outcome: post-operative delirium, psychiatric symptoms, and pain
Key exclusion criteria
Trials with different target drugs
Trials without outcome assessment
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Kotake |
Organization
Okayamasaiseikai General Hospital
Division name
Department of pharmacy
Zip code
700-8511
Address
2-25, Kokutai-cho, Kita-ku, Okayama City, Okayama
TEL
086-252-2211
kottanketty@gmail.com
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Kotake |
Organization
Okayamasaiseikai General Hospital
Division name
Department of pharmacy
Zip code
700-8511
Address
2-25, Kokutai-cho, Kita-ku, Okayama City, Okayama
TEL
086-252-2211
Homepage URL
kottanketty@gmail.com
Sponsor or person
Institute
Okayamasaiseikai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Okayamasaiseikai General Hospital
Address
2-25, Kokutai-cho, Kita-ku, Okayama City, Okayama
Tel
086-252-2211
chiken-hp@okayamasaiseikai.or.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 13 | 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
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056994
| Research Plan | |
|---|---|
| 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 |
