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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023123
Receipt No. R000026460
Scientific Title Investigation about protective effect of the aspiration pneumonia using the press tack needle in regional medicine.
Date of disclosure of the study information 2016/07/12
Last modified on 2016/07/12

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Basic information
Public title Investigation about protective effect of the aspiration pneumonia using the press tack needle in regional medicine.
Acronym Investigation about protective effect of the aspiration pneumonia using the press tack needle.
Scientific Title Investigation about protective effect of the aspiration pneumonia using the press tack needle in regional medicine.
Scientific Title:Acronym Investigation about protective effect of the aspiration pneumonia using the press tack needle.
Region
Japan

Condition
Condition Aspiration pneumonitis
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation about the aspiration pneumonitis protective effect of the press tack needle stimulation for patients with cerebrovascular disorder sequelae with a history of the aspiration pneumonitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of occurrence of aspiration pneumonitis during study period
Key secondary outcomes Latent time of swallowing reflex
Substance P concentrations in saliva
Mini Mental State Examination
Barthel Index
Body mass index
Examination of drawing blood
The number of fever during study period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 PYONEX ZERO
A period of the intervention: one year
Quantity of the intervention: two places (four places in total) of ST-36 (anterior surface of lag), KI-3 (the rear of the malleolus medialis)
The number of times of the intervention: continuation pasting (we put it twice a week and change it)
Interventions/Control_2 Sham PYONEX ZERO
A period of the intervention: one year
Quantity of the intervention: two places (four places in total) of ST-36 (anterior surface of lag), KI-3 (the rear of the malleolus medialis)
The number of times of the intervention: continuation pasting (we put it twice a week and change it)
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
100 years-old >=
Gender Male and Female
Key inclusion criteria The in and out patients in the collaborative investigation institution.
The patients who receive at-home medical care in the collaborative investigation institution.
Key exclusion criteria The patients with the serious disease that can produce pneumonia with chronic respiratory disease, malignant tumor, chronic ischemic disease.
The patients that oral cannot take a therapeutic drug.
The patients with the allergy to metal.
The patients with severe skin reaction.
The patients whom a deglutition reflex does not occur in at initial LTSR measurement.
The patients whom aspiration pneumonitis develops in with serious case that is more than three times during the past three months.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichiro Kaneko
Organization Tohoku University Hospital
Division name Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan
TEL 022-717-7507
Email souichi0134@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Soichiro Kaneko
Organization Tohoku University Hospital
Division name Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan
TEL 022-717-7507
Homepage URL
Email souichi0134@gmail.com

Sponsor
Institute Tohoku University Hospital
Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 07 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
2016 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 20 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
2016 Year 07 Month 11 Day
Last modified on
2016 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026460

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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