UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006167 |
|---|---|
| Receipt number | R000007288 |
| Scientific Title | Open randomized comparative study on the prevention of dementia by acupuncture with the improvement of life style |
| Date of disclosure of the study information | 2011/08/15 |
| Last modified on | 2011/08/13 16:03:27 |
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Basic information
Public title
Open randomized comparative study on the prevention of dementia by acupuncture with the improvement of life style
Acronym
Open randomized comparative study on the prevention of dementia by acupuncture
Scientific Title
Open randomized comparative study on the prevention of dementia by acupuncture with the improvement of life style
Scientific Title:Acronym
Open randomized comparative study on the prevention of dementia by acupuncture
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of acupuncture and the improvement of life style on the prevention of dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function (MMSE, WMS-R)
Key secondary outcomes
Actigraphy and immunological parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Acupuncture and transcutaneous electrical acupuncture-point stimulation
Interventions/Control_2
Improvement of life style
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.More than 60year old to less than 75 year old
2.Male and female
3.Judged to be capable of informed consent and compliance during study
Key exclusion criteria
1.Dementia
2.Severe disease including depression and hypothyroidism
3.Taking drugs or dietary supplement influencing the outcome of this study
4.acute or chronic disease which influence outcome of this study
5.Severe changes in life style
6.Judged to be inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Imanishi |
Organization
Kyoto Prefetural Unversity of Medicine
Division name
Department of Microbiology
Zip code
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5330
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Imanishi |
Organization
Kyoto Prefetural Unversity of Medicine
Division name
Department of Microbiology
Zip code
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5330
Homepage URL
imanishi-micro@nifty.com
Sponsor or person
Institute
Kyoto Prefetural Unversity of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural Center for Preventive Medicine
Organization
Division
Category of Funding Organization
Local Government
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
京都府立医科大学
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 15 | 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
It is clarified that acupuncture increased the cognitive function, and expected that it is useful for the prevention of dementia.
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
| 2008 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 13 | Day |
Last modified on
| 2011 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007288
