UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect for autonomic nervous system through vibrational stimulation to the following acupuncture points, LI11 and PC6.
Title of the study (Brief title)	Vibrational stimulation to LI11 and PC6.
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate effect for autonomic nervous system through vibrational stimulation to the following acupuncture points, LI11 and PC6.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Whether vibrational stimulation show same effect as real acupuncture.
Key secondary outcomes	Whether vibrational frequency 128Hz, same as medical tuning folk, is effective or not.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Instead of real acupuncture, 128Hz vibration is given for 30 minutes.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults
Key exclusion criteria	heart disease like Arrhythmia Allergy to stainless steel
Target sample size	20

Research contact person
Name of lead principal investigator	Masayoshi Ichie
Organization	Tohoku university
Division name	Graduate school of medicine
Address	2-1, Aoba-ku, Sendai, Japan
TEL	022-717-7457
Email	ichie@music.med.tohoku.ac.jp

Public contact
Name of contact person	Masayoshi Ichie
Organization	Tohoku university
Division name	Graduate school of medicine
Address	2-1, Aoba-ku, Sendai, Japan
TEL	022-717-7457
Homepage URL
Email	ichie@music.med.tohoku.ac.jp

Sponsor
Institute	Tohoku university
Institute
Department

Funding Source
Organization	Tohoku university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2016 Year 09 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 26 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2017 Year 03 Month 14 Day
Date of closure to data entry	2017 Year 03 Month 14 Day
Date trial data considered complete	2017 Year 03 Month 14 Day
Date analysis concluded	2017 Year 03 Month 14 Day

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

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2017 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027611