臨床研究等提出・公開システム

Scientific Title	Effect of capacitive - resistive electric transfer (CRet) on local blood circulation and skin superficial / deep temperature (Effect of capacitive - resistive electric transfer (CRet))
Public Title	Effect of capacitive - resistive electric transfer (CRet) on local blood circulation and skin superficial / deep temperature

Study end date
Performed Number of Subjects
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links	International Journal of Hyperthermia

Contact for Scientific Queries	Investigator Name	Aoyama Tomoki
	Investigator Organization	Kyoto University Graduate School of Medicine
	Address	53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507
	TEL	+81-75-751-3935
	E-mail	aoyama.tomoki.4e@kyoto-u.ac.jp
Contact for Public Queries	Contact Name	Tashiro Yuto
	Contact Organization	Kyoto University Graduate School of Medicine
	Address	53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507
	TEL	+81-75-751-3935
	E-mail	tashirow.y@gmail.com

Recruitment Status	COMPLETED

Date of First Enrollment		Jan. 31, 2016
Planned Number of Subjects		13
Nature of Investigation		Interventional
Study Design	Description of Trial Design	comparison test between groups
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	healthy adults
	Exclusion Criteria	cardiac disorder pulmonary disorder severe musculoskeletal disorder
	Minimum Age	20age old exceed
	Maximum Age	40age old not
	Sex of Participants	Male
Trial Indication(s)		lower back
Intervention(s)		Intervention type:DEVICE Name of intervention:thermotherapy,hotpack Dose form / Japanese Medical Device Nomenclature:DEVICE,DEVICE indiba,hotpack Route of administration / Site of application:CUTANEOUS,CUTANEOUS Dose per administration:1,1 15,15 minutes,minutes Dosing frequency / Frequency of use:QD,QD times,1 Planned duration of intervention:3 days,3days Intended dose regimen:none,none detailes of teratment arms:15 minutes of indiba intervention,15 minutes of hotpack intervention Comparative intervention name:healthy adults Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application:CUTANEOUS Dose per administration:1 15 minutes Dosing frequency / Frequency of use:QD 3 Planned duration of intervention:3 days Intended dose regimen:none
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		local blood flow and temperature
Secondary Outcome(s)		none

Primary Sponsor	Aoyama Tomoki
Secondary Sponsor	Tashiro Yuto

Sources of funding	self funding

Name of Ethics Committee	Kyoto University Graduate School and Faculty of. Medicine, Ethics Committee
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Feb. 16, 2016

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Secondary Study ID	Nill Known
Issuer Name

Secondary Study ID	JMA-IIA00238
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	July. 13, 2019	(this page)	Changes
1	Jan. 19, 2016	Detail

List of change history