UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058836 |
|---|---|
| Receipt number | R000067278 |
| Scientific Title | Effects of wearing a test substance that generates far-infrared rays and weak electric currents on concentration and physical range of motion: a randomized, double blind, placebo-controlled study |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/19 13:27:55 |
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Basic information
Public title
Effects of wearing a test substance that generates far-infrared rays and weak electric currents on concentration and physical range of motion.
Acronym
RES study
Scientific Title
Effects of wearing a test substance that generates far-infrared rays and weak electric currents on concentration and physical range of motion: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym
Effects of wearing a test substance that generates far-infrared rays and weak electric currents on concentration and physical range of motion.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effects of wearing test products on concentration and physical range of motion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration Assessment Test, measurement of physical range of motion
Key secondary outcomes
subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For concentration assessment, the hat-type device (test product) was worn once, and for range of motion assessment, the ankle band-type device (test product) was worn for two weeks.
Interventions/Control_2
For concentration assessment, the hat-type device (placebo) was worn once, and for range of motion assessment, the ankle band-type device (placebo) was worn for two weeks.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects who suffer from fatigue, stiff shoulders, or lower back pain
2.Subjects who feel a decline in concentration or find it difficult to focus
Key exclusion criteria
1. Subjects with a history of treatment that may have affected the test site.
2. Subjects with color vision deficiency (reduced color perception).
3. Subjects unable to wash the test product.
4. Subjects who have started taking a new medication within the past two months.
5. Subjects currently attending chiropractic clinics, gyms, or yoga classes.
6. Subjects planning to change their lifestyle during the study period.
7. Subjects who have participated in or plan to participate in other clinical trials within the past month prior to consent acquisition.
8. Subjects who are currently pregnant or breastfeeding (including those who have recently given birth).
9. Subjects with alcoholism or heavy smokers.
10. Subjects with a history of food or contact allergies.
11. Subjects receiving hormone replacement therapy.
12. Subjects unable to walk independently without assistance.
13. Subjects suspected of mild or severe dementia.
14. Subjects deemed inappropriate by the principal investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Relive Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2025 | Year | 08 | 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
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067278
