UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002133 |
|---|---|
| Receipt number | R000002606 |
| Scientific Title | The effect of press tack needles on the swallowing reflex in the elderly. |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2013/07/02 11:51:37 |
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Basic information
Public title
The effect of press tack needles on the swallowing reflex in the elderly.
Acronym
The effect of press tack needles on the swallowing reflex in the elderly.
Scientific Title
The effect of press tack needles on the swallowing reflex in the elderly.
Scientific Title:Acronym
The effect of press tack needles on the swallowing reflex in the elderly.
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Medicine in general | Pneumology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether acupuncture therapy with press tack needles can improve the swallowing reflex in the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of swallowing reflex.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Press tack needles on acupoints
Interventions/Control_2
Sham needles on acupoints
Interventions/Control_3
Press tack needles on sham points
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
elder patients with cerebrovascular diseases
Key exclusion criteria
patients obviously showing a symptom
of pneumonia
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Seki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Traditional Asian Medicine
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7185
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Seki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Traditional Asian Medicine
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Department of Traditional Asian Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | 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
| 2009 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 29 | Day |
Last modified on
| 2013 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002606
