UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024008 |
|---|---|
| Receipt number | R000027611 |
| Scientific Title | Effect for autonomic nervous system through vibrational stimulation to the following acupuncture points, LI11 and PC6. |
| Date of disclosure of the study information | 2016/09/27 |
| Last modified on | 2017/03/14 21:55:34 |
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Basic information
Public title
Effect for autonomic nervous system through vibrational stimulation to the following acupuncture points, LI11 and PC6.
Acronym
Vibrational stimulation to LI11 and PC6.
Scientific Title
Effect for autonomic nervous system through vibrational stimulation to the following acupuncture points, LI11 and PC6.
Scientific Title:Acronym
Vibrational stimulation to LI11 and PC6.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate effect for autonomic nervous system through vibrational stimulation to the following acupuncture points, LI11 and PC6.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether vibrational stimulation show same effect as real acupuncture.
Key secondary outcomes
Whether vibrational frequency 128Hz, same as medical tuning folk, is effective or not.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Instead of real acupuncture, 128Hz vibration is given for 30 minutes.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
heart disease like Arrhythmia
Allergy to stainless steel
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Ichie |
Organization
Tohoku university
Division name
Graduate school of medicine
Zip code
Address
2-1, Aoba-ku, Sendai, Japan
TEL
022-717-7457
ichie@music.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Ichie |
Organization
Tohoku university
Division name
Graduate school of medicine
Zip code
Address
2-1, Aoba-ku, Sendai, Japan
TEL
022-717-7457
Homepage URL
ichie@music.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
Tohoku university
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 12 | Day |
Last modified on
| 2017 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027611
