UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006251 |
|---|---|
| Receipt number | R000007400 |
| Scientific Title | Study of the influences of Yokukansan for sleep disturbance in dementia. |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2014/08/10 15:36:42 |
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Basic information
Public title
Study of the influences of Yokukansan for sleep disturbance in dementia.
Acronym
Study of the influences of Yokukansan for sleep disturbance in dementia.
Scientific Title
Study of the influences of Yokukansan for sleep disturbance in dementia.
Scientific Title:Acronym
Study of the influences of Yokukansan for sleep disturbance in dementia.
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the influences of Yokukansan on sleep disturbance in dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep Disorders Inventory (SDI)
Key secondary outcomes
Neuropsychiatric Inventory-Q-J
(NPI-Q-J)
Sleep outcome measured via actigraph
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TSUMURA Yokukansan Extract Granules
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
| 55 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with dementia
2) Patients with sleep disorder behaviors on the SDI
3) Serum potassium level should be in normal range
4) Those who have a caregiver able to provide an independent evaluation of functioning
Key exclusion criteria
1) Patients with sleep disturbance related to the acute sleep disturbance, delirium and depression
2) Presence of severe illness
3) Those who have joined any clinical trial within 3 month
4) Those who are thought inadequate by their doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Ishida |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Psychiatry, Department of Clinical Neuroscience
Zip code
Address
5200 Kihara, Kiyotake-cho, Miyazaki, 889-1692, Japan
TEL
+81-985-852969
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihito Hayashi |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Psychiatry, Department of Clinical Neuroscience
Zip code
Address
5200 Kihara, Kiyotake-cho, Miyazaki, 889-1692, Japan
TEL
0985-85-2969
Homepage URL
Sponsor or person
Institute
Division of Psychiatry, Department of Clinical Neuroscience, Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Psychogeriatric Center, Daigo Hospital
Keimei Memorial 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
大悟病院 老年期精神疾患センター(宮崎県)
けいめい記念病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
| 2011 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 30 | Day |
Last modified on
| 2014 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007400
