UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009232 |
|---|---|
| Receipt number | R000010837 |
| Scientific Title | Validation of tests for cognitive function, and the effect of Yokukansankachimpihange on cognitive and non-cognitive symptoms |
| Date of disclosure of the study information | 2012/10/31 |
| Last modified on | 2013/11/22 15:47:01 |
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Basic information
Public title
Validation of tests for cognitive function, and the effect of Yokukansankachimpihange on cognitive and non-cognitive symptoms
Acronym
Validation of tests for cognitive function, and the effect of Yokukansankachimpihange on cognitive and non-cognitive symptoms
Scientific Title
Validation of tests for cognitive function, and the effect of Yokukansankachimpihange on cognitive and non-cognitive symptoms
Scientific Title:Acronym
Validation of tests for cognitive function, and the effect of Yokukansankachimpihange on cognitive and non-cognitive symptoms
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Geriatrics | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of test for cognitive function, and the effect of Yokukansankachimpihange on cognitive and non-cognitive symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Yokukansankachimpihange is administered for 4 weeks to participants with mild dementia, and changes in core symptoms of dementia are compared with those in the control group.
Key secondary outcomes
Yokukansankachimpihange is administered for 4 weeks to participants with mild dementia, and changes in peripheral symptoms of dementia are compared with those in the control group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participants in the active group take one packet of Yokukansankachimpihange, twice a day, for 4 weeks. They are asked to keep their diet and daily activity as usual as possible.
Interventions/Control_2
Those in the control group take no packets. They are asked to keep their diet and daily activity as usual as possible.
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following types of subjects are invited to the trial: those with intermediate physical strength, easy fatigability and irritability, insomnia, and mild psychotic symptoms.
Key exclusion criteria
The following subjects are excluded: those with very week digestive tracts; those with severe disorders of internal organs (including severe blood and metabolic disorders), or histories of them; those with drug allergy; and also those who doctors in charge of the trial think are inappropriate for the trial.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Hamazaki |
Organization
Polyene Project, Inc.
Division name
Department of Clinical Trial Management
Zip code
Address
3-3-8 Bunkyo-machi, Toyama-city, Toyama 9300876
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Hamazaki |
Organization
Polyene Project, Inc.
Division name
Department of Clinical Trial Management
Zip code
Address
3-3-8 Bunkyo-machi, Toyama-city, Toyama 9300876
TEL
Homepage URL
keihama@med.u-toyama.ac.jp
Sponsor or person
Institute
Polyene Project, Inc.
Institute
Department
Personal name
Funding Source
Organization
Kracie Pharma, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
清幸会 島田病院（富山県）、城南会 富山城南温泉病院（富山県）、秀愛会 あゆみの郷（富山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | 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
| 2012 | Year | 10 | Month | 31 | Day |
Last modified on
| 2013 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010837
| 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 |
