UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038370 |
|---|---|
| Receipt number | R000043464 |
| Scientific Title | Influence on blood pressure regulation mechanism via autonomic nerve by electroacupuncuture stimulation in healthy subjects |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/04/23 12:08:08 |
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Basic information
Public title
Influence on blood pressure regulation mechanism via autonomic nerve by electroacupuncuture stimulation in healthy subjects
Acronym
Influence on blood pressure regulation mechanism via autonomic nerve by electroacupuncuture stimulation in healthy subjects
Scientific Title
Influence on blood pressure regulation mechanism via autonomic nerve by electroacupuncuture stimulation in healthy subjects
Scientific Title:Acronym
Influence on blood pressure regulation mechanism via autonomic nerve by electroacupuncuture stimulation in healthy subjects
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of electroacupuncture on blood pressure regulation mechanisms via autonomic nerves in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation items are blood pressure, autonomic nerve activity (LF / HF power spectrum analysis), blood stress hormones (noradrenaline, adrenaline, renin, aldosterone).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Electricacupuncture energize at both sites for LR3 and ST36, and apply power to 3.3-3.5V for 2Hz for 10 minutes. After that, the grasping movement is continuously grasped for 3 minutes at 30% of the maximum muscle strength, and data is collected immediately after that. Collect blood twice 15 minutes after the start of resting position and after the end of continuous grasping exercise
Interventions/Control_2
Although the procedure of energization stimulation is performed, the stimulation is not performed and the machine is operated, but the actual energization is not performed. Grip exercise is performed in the same way as Intervention 1, and the same data collection as Intervention 1 is performed.
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
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult man over 20 years old
Key exclusion criteria
Persons diagnosed with hypertension
Patients with a history of heart disease such as ischemic heart disease or valvular disease
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | hidero |
| Middle name | |
| Last name | takahashi |
Organization
Morinomiya University of Medical Sciences
Division name
Department of Acupuncture,Facuty of Health Sciences
Zip code
559-8611
Address
1-26-16 Nankokita Suminoe-Ku Osaka-Shi Osaka
TEL
06-6616-6911
h-takahashi@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | hidero |
| Middle name | |
| Last name | takahashi |
Organization
Morinomiya University of Medical Sciences
Division name
Department of Acupuncture,Facuty of Health Sciences
Zip code
559-8611
Address
1-26-16 Nankokita Suminoe-Ku Osaka-Shi Osaka
TEL
06-6616-6911
Homepage URL
h-takahashi@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Morinomiya University of Medical Sciences
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
Support center for Research Studies Ethics Review Subcommittee,Morinomiya University of Medical Sciences
Address
1-26-16 Nankokita Suminoe-Ku Osaka-Shi Osaka
Tel
0666166911
shinsabukai@morinomiya-u.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
| 2019 | Year | 11 | 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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 10 | Month | 23 | Day |
Last modified on
| 2020 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043464
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
