UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030578 |
|---|---|
| Receipt number | R000034913 |
| Scientific Title | Heart rate variability analysis of the effect of electro- acupuncture stimulation on circulation regulation system |
| Date of disclosure of the study information | 2017/12/26 |
| Last modified on | 2019/02/22 22:05:03 |
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Basic information
Public title
Heart rate variability analysis of the effect of electro-
acupuncture stimulation on circulation regulation system
Acronym
Heart rate variability analysis of the effect of electro-acupuncture stimulation on circulation regulation system
Scientific Title
Heart rate variability analysis of the effect of electro-
acupuncture stimulation on circulation regulation system
Scientific Title:Acronym
Heart rate variability analysis of the effect of electro-acupuncture stimulation on circulation regulation system
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of acupuncture stimulation on the circulation regulatory system by heart rate variability analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
heart rate variability
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
electro-acupuncture stimulation
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
healty adult
Key exclusion criteria
those who considered to be inappropriate by doctors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichiro Hayano |
Organization
Nagoya City Universty
Division name
Hayano Bio-Signal Labolatory
Zip code
Address
Azakawasumi,Mizuho-cho,Mizuho-ku,Nagoya-city,Aichi
TEL
(+81)-52-853-8499
hayano.biosignal.lab@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichiro Hayano |
Organization
Nagoya City Universty
Division name
Hayano Bio-Signal Labolatory
Zip code
Address
Azakawasumi,Mizuho-cho,Mizuho-ku,Nagoya-city,Aich
TEL
(+81)-52-853-8499
Homepage URL
hayano.biosignal.lab@gmail.com
Sponsor or person
Institute
Nagoya City Universty
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Universty
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
名古屋市立大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 26 | 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
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 26 | 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
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034913
