UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008407 |
|---|---|
| Receipt number | R000009890 |
| Scientific Title | Observational research on efficacy and safety of Yokukansan in behavioral and psychological symptoms of dementia with Lewy bodies. |
| Date of disclosure of the study information | 2012/07/11 |
| Last modified on | 2013/01/24 17:48:14 |
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Basic information
Public title
Observational research on efficacy and safety of Yokukansan in behavioral and psychological symptoms of dementia with Lewy bodies.
Acronym
Observational research on Yokukansan in behavioral and psychological symptoms of dementia with Lewy bodies.
Scientific Title
Observational research on efficacy and safety of Yokukansan in behavioral and psychological symptoms of dementia with Lewy bodies.
Scientific Title:Acronym
Observational research on Yokukansan in behavioral and psychological symptoms of dementia with Lewy bodies.
Region
| Japan |
Condition
Condition
Dementia with Lewy bodies patient having behavioral and psychological symptoms
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study observationally efficacy and safety of TSUMURA Yokukansan (TJ-54) in the long-term treatment of behavioral and psychological symptoms of dementia with Lewy bodies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in neuropsychiatric inventory (NPI) score before and after TJ-54 treatment
Key secondary outcomes
Changes in serum potassium level before and after TJ-54 treatment
Incidence rate of adverse reaction
Base
Study type
Observational
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
Patient who was diagnosed dementia with Lewy bodies and has BPSD
Patient who was prescribed TJ-54
Key exclusion criteria
When a patient refuses to join the research
When a doctor judged a patient not appropriate to join the research based on medical or social reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Okahara |
Organization
Keimei Memorial Hospital
Division name
Neurosurgery
Zip code
Address
762 Iwachino, Kunitomi-cho, Higashimorokata, Miyazaki 880-1111, Japan
TEL
0985-75-7007
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keimei Memorial Hospital
Division name
Neurosurgery
Zip code
Address
762 Iwachino, Kunitomi-cho, Higashimorokata, Miyazaki 880-1111, Japan
TEL
0985-75-7007
Homepage URL
Sponsor or person
Institute
Keimei Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsumura & Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tsumura & Co.
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
| 2012 | Year | 07 | Month | 11 | 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
| 2012 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
To study retrospective-observationally efficacy and safety of TSUMURA Yokukansan (TJ-54) in the long-term treatment of behavioral and psychological symptoms of dementia with Lewy bodies.
Assessment:Changes in neuropsychiatric inventory (NPI) score before and after TJ-54 treatment
Changes in serum potassium level before and after TJ-54 treatment
Incidence rate of adverse reaction
Management information
Registered date
| 2012 | Year | 07 | Month | 11 | Day |
Last modified on
| 2013 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009890
