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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035519
Receipt No. 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

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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
Email 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
Email tamai@thu.ac.jp

Sponsor
Institute Faculty of Health Care and Medical Sports, Teikyo Heisei University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040376

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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