UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047940 |
|---|---|
| Receipt number | R000054644 |
| Scientific Title | Change and repeatability of heart rate by acupuncture stimulation Evaluation by heart rate variability analysis in man |
| Date of disclosure of the study information | 2022/06/06 |
| Last modified on | 2023/03/06 14:38:11 |
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Basic information
Public title
Change and repeatability of heart rate by acupuncture stimulation
Evaluation by heart rate variability analysis in man
Acronym
Change and repeatability of heart rate by acupuncture stimulation
Scientific Title
Change and repeatability of heart rate by acupuncture stimulation
Evaluation by heart rate variability analysis in man
Scientific Title:Acronym
Change and repeatability of heart rate by acupuncture stimulation
Region
| Japan |
Condition
Condition
Healthy condition
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will repeat measurements on the same subjects to see if the acupuncture-induced heart rate reduction response can be reproduced. In addition, cardiac autonomic function will be evaluated based on heart rate variability (HRV) analysis, and its correlation with the heart rate reduction response will also be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of electrocardiogram: Electrodes are placed on the chest induction I and recordings are made. The instantaneous heart rate is calculated from the R-R interval of the recorded ECG. In addition, HRV analysis is performed as an indicator of cardiac autonomic function.
The ECG is measured for 5 minutes before stimulation, 90 seconds during stimulation, and 5 minutes after stimulation, for a total of 11 minutes and 30 seconds.
Key secondary outcomes
Assessment of the type of pain: The presence or absence of "pain" or "de qi" during the stimulation will be assessed after the end of the experiment.
Evaluation of the degree of pain: The intensity of the "pain" or "de qi" is assessed using a visual analogue scale (VAS) of 10 cm in width, respectively, with 100 points as the most intense pain on a scale of every 1 mm, and 0 as the scale indicating no pain.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The site of acupuncture stimulation is the left-side Hegu (LI4) point on the outside the midpoint of the second metacarpal bone. The acupuncture stimulation is applied by the sparrow pecking method; that is, the acupuncture needle is inserted and move vertically at the frequency of 1 Hz at a depth of 15-20 mm for 90 seconds. Disposable stainless steel needles (40 mm , 0.20 mm) are used.
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
1) Healthy person aged 20 and under 30
2) Those who can attend the study site within the study period
3) Persons who can get written consent for participation in this study
Key exclusion criteria
1) Persons who go to the hospital or take medication for basic diseases (chronic respiratory diseases, heart diseases, kidney diseases, liver diseases, diabetes, blood diseases (hyponatremia, difficult-to-treat high blood pressure, etc.), immune function Decreasing illnesses (including malignant tumors), neurological disorders, neuromuscular disorders and severe mental illnesses)
2) Persons with extremely short sleep (less than 5 hours a day) and those with long sleep (10 hours or more a day)
3) Persons who complain of poor physical condition due to sleep disorders
4) Persons who have a habit of excessive smoking * 1 and excessive alcohol intake * 2, and those who have an extremely irregular diet * 3
5) Persons with significant abnormalities in blood pressure, blood test, urine test, etc.
6) Those who donated 400 ml of blood within 12 weeks, 200 ml of blood within 4 weeks, and component blood within 2 weeks before the start of the experiment
7) Persons participating in other clinical trials
<Notes>
* 1 Excessive smoking generally means smoking 21 or more cigarettes a day.
* 2 Excessive alcohol intake is roughly equivalent to 2 cups of sake per day (500 ml of beer bottle x 2 bottles, whiskey double 60 ml x 2 cups, 1 go of shochu 180 ml, 1 cup of red wine glass 60 ml x 7 cups) or more. Refers to drinking.
* 3 Refers to a state in which one or more meals a day are one or more meals, and the meal time is constantly irregular.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Imai |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL
080-1527-1617
k.imai@thu.ac.jp
Public contact
Name of contact person
| 1st name | Namiki |
| Middle name | |
| Last name | Shinozaki |
Organization
Teikyo Heisei University
Division name
Department of Acupuncture and Moxibustion, Graduate School of Health Sciences
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL
080-7698-1412
Homepage URL
n.shinozaki1@gmail.com
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei 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
ethical commitie, Teikyo Heisei University
Address
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
Tel
03-5843-3111
rec@thu.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
| 2022 | Year | 06 | Month | 06 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054644
