UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054779 |
|---|---|
| Receipt number | R000062603 |
| Scientific Title | Effect of wearing "RELIVE Shirt" and "RELIVE Spats" to increase blood flow: open study |
| Date of disclosure of the study information | 2024/06/26 |
| Last modified on | 2024/12/03 09:54:44 |
* 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 wearing "RELIVE Shirt" and "RELIVE Spats" to increase blood flow
Acronym
RSS blood flow study
Scientific Title
Effect of wearing "RELIVE Shirt" and "RELIVE Spats" to increase blood flow: open study
Scientific Title:Acronym
Effect of wearing "RELIVE Shirt" and "RELIVE Spats" to increase blood flow
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of wearing the test article on blood flow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood Flow Measurement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing test article(Shirts, spats)
Interventions/Control_2
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 have started taking a new medication within the last 2 months
3. Subjects who attend chiropractic clinics, sports gyms, or yoga classes
4. Subjects who plan to change their lifestyle during the study period (including starting or stopping a diet, getting enough sleep from now on, etc.)
5. 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
6. Subjects who are pregnant or breastfeeding, or those who plan to do so (including subjects who have just given birth)
7. Subjects with alcoholism or heavy smokers
8. Subjects with a history of food allergies
9. Subjects receiving hormone replacement therapy
10. Subjects who cannot walk independently without assistance
11. Subjects suspected of mild or severe dementia
12. Others who the principal investigator deems inappropriate
Target sample size
10
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 | 26 | 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
11
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 | 26 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 26 | 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 | 26 | 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=R000062603
