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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006167
Receipt No. 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

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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
Email

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
Email imanishi-micro@nifty.com

Sponsor
Institute Kyoto Prefetural Unversity of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007288

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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