UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054566 |
|---|---|
| Receipt number | R000062352 |
| Scientific Title | Physical effects of wearing "RELIVE shirts" and "RELIVE spats": single blinded study |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2024/12/03 09:55:09 |
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Basic information
Public title
Physical effects of wearing "RELIVE shirts" and "RELIVE spats"
Acronym
RSS study
Scientific Title
Physical effects of wearing "RELIVE shirts" and "RELIVE spats": single blinded study
Scientific Title:Acronym
Physical effects of wearing "RELIVE shirts" and "RELIVE spats"
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of wearing the test product on range of motion and movement of the body
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measurement, VAS (Before and after wear, 2 weeks later)
Key secondary outcomes
subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wear test articles (Shirts, spats) for 2 weeks (daytime and bedtime)
Interventions/Control_2
Wear placebos (Shirts, spats) for 2 weeks (daytime and bedtime)
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with fatigue, stiff shoulders, back pain, etc.
Key exclusion criteria
1.Subjects with a history of treatment that affects the test site
2.Subjects who are unable to wash the test product
3.Subjects who have started taking a new medication within the last 2 months
4. Subjects who attend chiropractic clinics, sports gyms, or yoga classes
5. Subjects who plan to change their lifestyle during the study period (including starting or stopping a diet, getting enough sleep from now on, etc.)
6. Subjects who have participated in other clinical trials within one month prior to obtaining consent, or subjects who plan to participate in other clinical trials
7. Subjects who are pregnant or breastfeeding, or those who plan to do so (including subjects who have just given birth)
8. Subjects with alcoholism or heavy smokers
9. Subjects with a history of food allergies
10. Subjects receiving hormone replacement therapy
11. Subjects who cannot walk independently without assistance
12. Subjects suspected of mild or severe dementia
13. Others who the principal investigator deems inappropriate
Target sample size
22
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
| 2024 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://ajcam.biz/gattkai/index.html
Number of participants that the trial has enrolled
23
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 28 | 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 | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062352
