UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052617 |
|---|---|
| Receipt number | R000060015 |
| Scientific Title | Research on changes in blood flow with the use of home-use far-infrared blood circulation-promoting clothing(A.A.TH textile products) |
| Date of disclosure of the study information | 2023/10/26 |
| Last modified on | 2023/10/25 20:18:49 |
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Basic information
Public title
Research on changes in blood flow with the use of home-use far-infrared blood circulation-promoting clothing
Acronym
Research on changes in blood flow with the use of home-use far-infrared blood circulation-promoting clothing
Scientific Title
Research on changes in blood flow with the use of home-use far-infrared blood circulation-promoting clothing(A.A.TH textile products)
Scientific Title:Acronym
Research on changes in blood flow with the use of home-use far-infrared blood circulation-promoting clothing
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare changes over time in blood flow, blood pressure, and body temperature under conditions in which far-infrared blood circulation-promoting clothing (A.A.TH Textile Products)for home use are used and under conditions in which ordinary fiber clothing are used.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood flow
Key secondary outcomes
body temperature,blood pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use of A.A.TH textile products
Interventions/Control_2
Use of placebo products
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
Subjects who have given a full explanation of their participation in this study and who have given their free and voluntary written consent.
Key exclusion criteria
1) Patients with severe arterial blood circulation disorder and congestive heart failure, post skin graft, necrosis/gangrene, severe edema, pyogenic skin disease, etc.
2) Patients with bleeding tendency or bleeding symptoms
3) Subjects taking drugs that affect hemodynamics for treatment of heart disease, hypertension, etc.
4) Other subjects judged inappropriate by the principal investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Hanzawa |
Organization
Niigata University Graduate School of Medicine and Dental Sciences
Division name
Advanced Treatment and Prevention for Vascular Disease and Embolism
Zip code
951-8510
Address
1-757 Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
TEL
025-368-9108
vasc-niigata@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Hanzawa |
Organization
Niigata University Graduate School of Medicine and Dental Sciences
Division name
Advanced Treatment and Prevention for Vascular Disease and Embolism
Zip code
951-8510
Address
1-757 Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
TEL
025-368-9108
Homepage URL
vasc-niigata@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medicine and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
ONYONE 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
Niigata University
Address
1-757 Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
Tel
025-368-9108
vasc-niigata@med.niigata-u.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
| 2023 | Year | 10 | Month | 26 | 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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 02 | 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
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060015
