UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035519 |
|---|---|
| Receipt number | R000040376 |
| Scientific Title | The Effect of Cathode Direct Current Electric Acupuncture Stimulus to the Proximal Anterior Part of the Lower Limbs on Heart Rate and Lumbar Blood Flow |
| Date of disclosure of the study information | 2019/01/11 |
| Last modified on | 2019/01/11 14:44:31 |
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Basic information
Public title
The Effect of Cathode Direct Current Electric Acupuncture Stimulus to the Proximal Anterior Part of the Lower Limbs on Heart Rate and Lumbar Blood Flow
Acronym
The Effect of Cathode Direct Current Electric Acupuncture Stimulus to the Proximal Anterior Part of the Lower Limbs on Heart Rate and Lumbar Blood Flow
Scientific Title
The Effect of Cathode Direct Current Electric Acupuncture Stimulus to the Proximal Anterior Part of the Lower Limbs on Heart Rate and Lumbar Blood Flow
Scientific Title:Acronym
The Effect of Cathode Direct Current Electric Acupuncture Stimulus to the Proximal Anterior Part of the Lower Limbs on Heart Rate and Lumbar Blood Flow
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Effect of Cathode Direct Current Electric Acupuncture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acupuncture stimulation stimulation is applied to the front face of the lower leg for 10 minutes. At that time the blood flow at the back of the back was measured with near infrared laser light.
Key secondary outcomes
Acupuncture stimulation is applied to the front of the lower thigh. Measure heart rate with electrocardiograph.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture group
Interventions/Control_2
Acupuncture and direct current - 25 Micro amp group
Interventions/Control_3
Acupuncture and direct current -75 Micro amp group
Interventions/Control_4
Acupuncture and DC + 75 Micro amp group
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
A healthy male adult volunteer
Key exclusion criteria
Person going to hospital
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAMAI Kiyoshi |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care and Medical Sports
Zip code
Address
4-1, Uruidominami, Ichihara-shi, Chiba, 290-0170, Japan
TEL
0436-74-6183
tamai@thu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAMAI Kiyoshi |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care and Medical Sports
Zip code
Address
4-1, Uruidominami, Ichihara-shi, Chiba, 290-0170, Japan
TEL
0436-74-6183
Homepage URL
tamai@thu.ac.jp
Sponsor or person
Institute
Faculty of Health Care and Medical Sports, Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Mr. Kiyoshi TAMAI
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
| 2019 | Year | 01 | Month | 11 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | 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
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2019 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040376
