UMIN-CTR Clinical Trial

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
Email	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
Email	h-takahashi@morinomiya-u.ac.jp

Sponsor
Institute	Morinomiya University of Medical Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043464