UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023123 |
|---|---|
| Receipt number | R000026460 |
| Scientific Title | Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2022/10/13 14:04:16 |
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Basic information
Public title
Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial
Acronym
Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial
Scientific Title
Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial
Scientific Title:Acronym
Press needle for aspiration pneumonia prevention in older adults: study protocol for a randomized double-blind placebo-controlled trial
Region
| Japan |
Condition
Condition
aspiration pneumonia
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 | Kaneko |
| Middle name | |
| Last name | Soichiro |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan
TEL
022-717-7507
souichi0134@gmail.com
Public contact
Name of contact person
| 1st name | Kaneko |
| Middle name | |
| Last name | Soichiro |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan
TEL
022-717-7507
Homepage URL
souichi0134@gmail.com
Sponsor or person
Institute
Tohoku University Hospital
Department of Education and Support for Regional Medicine, Department of Kampo Medicine
Institute
Department
Personal name
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
Ethics Committee Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba ward, Sendai 980-8574, Japan.
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026460
| Research Plan | |
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| 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 |
