UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020374 |
|---|---|
| Receipt number | R000023532 |
| Scientific Title | Cost effectiveness of Yokukansan for BPSD(behavioral and psychologicalsymptoms of dementia) in Mild to Moderate Alzheimer's disease and Dementia with Lewy bodies. |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2016/01/25 09:31:02 |
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Basic information
Public title
Cost effectiveness of Yokukansan for BPSD(behavioral and psychologicalsymptoms of dementia) in Mild to Moderate Alzheimer's disease and Dementia with Lewy bodies.
Acronym
Cost effectiveness of Yokukansan for BPSD in Mild to Moderate AD and DLB.
Scientific Title
Cost effectiveness of Yokukansan for BPSD(behavioral and psychologicalsymptoms of dementia) in Mild to Moderate Alzheimer's disease and Dementia with Lewy bodies.
Scientific Title:Acronym
Cost effectiveness of Yokukansan for BPSD in Mild to Moderate AD and DLB.
Region
| Japan |
Condition
Condition
Alzheimer's disease and Dementia with Lewy bodies.
Classification by specialty
| Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the medical economic utility of yokukansan in dementia therapy
Basic objectives2
Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QALY (quality adjusted life year),The Change
of Cost (direct cost, indirect cost) of yokukansan administration group and the non-administration group of before and after therapy
Evaluation time : the time of introduction , 4 weeks , 12-14 weeks , 24-26 weeks , 52-54 weeks
Key secondary outcomes
NPI(Neuropsychiatric Inventory),MMSE(mini mental state exam)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
admistration of Yokukansan
Tsumura yokukansan granules 2.5g three times a day , administered during the test period
Interventions/Control_2
Non admistration 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It satisfies a diagnosis of dementia in DSM-5, dementia due to Alzheimer's disease, among those diagnosed with dementia with Lewy body disease, those with a neurosis or insomnia.
Neuropsychiatric Inventory subscale or more 6
Key exclusion criteria
Patients with a history of hypersensitivity to components of the yokukansan
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Yamada |
Organization
Tokyo Women's Medical University East Medical Center
Division name
Psychiatry
Zip code
Address
Arakawa-ku, Tokyo Nishiogu 2-1-10
TEL
03-3810-1111
yamadaps@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Noda |
Organization
Tokyo Women's Medical University East Medical Center
Division name
Psychiatry
Zip code
Address
Arakawa-ku, Tokyo Nishiogu 2-1-10
TEL
080-4425-3143
Homepage URL
noda1976@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Medical Center East psychiatric personnel expenses
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 01 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023532
