UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053905 |
|---|---|
| Receipt number | R000061539 |
| Scientific Title | Research to evaluate biological responses with tourmaline ore-containing terahertz shirts |
| Date of disclosure of the study information | 2024/03/19 |
| Last modified on | 2024/03/19 18:09:37 |
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Basic information
Public title
Research to evaluate biological responses with tourmaline ore-containing terahertz shirts
Acronym
Effects of tourmaline ore-containing terahertz shirts
Scientific Title
Research to evaluate biological responses with tourmaline ore-containing terahertz shirts
Scientific Title:Acronym
Biological response with tourmaline ore-containing terahertz shirts
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the effects of tourmaline/terahertz shirts on the organism and changes in bodily functions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
sleeping hours
Key secondary outcomes
Restlessness, anger, joy, sadness, liveliness, REM sleep, shallow sleep, deep sleep, number of awakenings, wake time, SpO2, number of steps, distance, calories expended, resting heart rate, weight, skeletal muscle mass, body fat percentage, body fat mass, BMI, muscle strength, muscle hardness, muscle luminosity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Wear tourmaline terahertz shirt for three weeks
Interventions/Control_2
Wear the placebo shirt for three 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Who can give consent to participate in the study
2) Who are able to use tourmaline/terahertz shirts and Fitbit trackers
Key exclusion criteria
1) if the Tourmaline Terahertz shirt and Fitbit tracker cannot be used
2) If you have been diagnosed with a sleep disorder by a doctor
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishinuki |
Organization
Sapporo Medical University
Division name
Department of Health and Sciences
Zip code
0608556
Address
W17, S1, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0116112111
tomohiro-ishi@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishinuki |
Organization
Sapporo Medical University
Division name
Department of Health and Sciences
Zip code
0608556
Address
W17, S1, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0116112111
Homepage URL
tomohiro-ishi@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Tomohiro Ishinuki
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
W17, S1, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
0116112111
tomohiro-ishi@sapmed.ac.jp
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
| 2024 | Year | 03 | Month | 19 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061539
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
