UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005454
Receipt number R000006454
Scientific Title Effect of far infrared energy radiation on human health
Date of disclosure of the study information 2011/04/20
Last modified on 2011/04/16 09:25:15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of far infrared energy radiation on human health

Acronym

Effect of FIR

Scientific Title

Effect of far infrared energy radiation on human health

Scientific Title:Acronym

Effect of FIR

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of cream and fiber containing rhyolite on human health, especially blood flow is analyzed and compared with massage by the hand radiating far infrared energy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Blood flow activation

Key secondary outcomes

Blood pressure, Electrocardiogram, Heart beat, Breathing, Blood oxygen, Saliva, Autonomic nerve condition, Mouth opening


Base

Study type

Interventional


Study design

Basic design

Parallel

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

NO

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Cream containing rhyolite

Interventions/Control_2

Fiber containing rhyolite

Interventions/Control_3

Massage

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy person

Key exclusion criteria

Disease of blood circulation

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kikuji Yamashita

Organization

Institute of Health Bioscience,
The University of Tokushima Graduate School

Division name

Oral and Maxillofacial Anatomy

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima

TEL

088-633-9120

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kikuji Yamashita

Organization

Institute of Health Bioscience, The University of Tokushima Graduate School

Division name

Oral and Maxillofacial Anatomy

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima

TEL

088-633-9120

Homepage URL


Email



Sponsor or person

Institute

Institute of Health Bioscience,
The University of Tokushima Graduate School

Institute

Department

Personal name



Funding Source

Organization

Matera Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

徳島大学大学院HBS研究部口腔顎顔面形態学分野


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 20 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

Preinitiation

Date of protocol fixation

2011 Year 04 Month 25 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2014 Year 04 Month 01 Day

Date of closure to data entry

2014 Year 04 Month 01 Day

Date trial data considered complete

2014 Year 04 Month 01 Day

Date analysis concluded

2014 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 04 Month 16 Day

Last modified on

2011 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006454


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name