UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	TAMAI Kiyoshi
Organization	Teikyo Heisei University
Division name	Faculty of Health Care and Medical Sports
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	TAMAI Kiyoshi
Organization	Teikyo Heisei University
Division name	Faculty of Health Care and Medical Sports
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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