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 |
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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
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
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
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
