UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063539 |
|---|---|
| Receipt number | R000072704 |
| Scientific Title | Clinical evaluation of home-use nitric oxide production-promoting blood circulation devices (skin gas NO measurement study and blood flow evaluation study) |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/05 20:12:14 |
* 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 specially treated textile products on skin gas and blood flow
Acronym
Skin gas NO and blood flow study
Scientific Title
Clinical evaluation of home-use nitric oxide production-promoting blood circulation devices (skin gas NO measurement study and blood flow evaluation study)
Scientific Title:Acronym
Skin gas NO measurement and blood flow evaluation study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of wearing specially treated textile products on skin gas nitric oxide and blood flow, compared with the same untreated products.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study I: nitric oxide concentration in skin gas (difference between treated and untreated products)
Study II: change in blood flow from before wearing (difference between treated and untreated products)
Key secondary outcomes
Body temperature, blood pressure, adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
| Device,equipment |
Interventions/Control_1
Participants wear the untreated product and are measured.
Interventions/Control_2
On the same day, participants then wear the treated product and are measured.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult men and women aged 20 to 69 years
Key exclusion criteria
1. Individuals taking medications that affect hemodynamics
2. Individuals with diseases affecting blood flow or thermoregulation, such as heart disease or hypertension
3. Individuals with skin disease or wounds at the wearing or measurement site, or prone to skin irritation
4. Women who are pregnant, may be pregnant, or are breastfeeding
5. Smokers
6. (Study I) Individuals who regularly take supplements that may affect nitric oxide production
7. Individuals participating in another clinical study, or within 4 weeks after completing one
8. Other individuals judged ineligible by the principal investigator
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Oshima |
Organization
Ligua Inc.
Division name
Product Marketing Department, Executive Officer
Zip code
541-0047
Address
2-6-6 Awajimachi, Chuo-ku, Osaka-shi, Osaka
TEL
06-6232-1800
md-qc@ligua.jp
Public contact
Name of contact person
| 1st name | Nami |
| Middle name | |
| Last name | Seike |
Organization
Ligua Inc.
Division name
Tokyo Office
Zip code
100-0014
Address
1-11-30 Nagatacho, Chiyoda-ku, Tokyo
TEL
03-3519-7813
Homepage URL
md-qc@ligua.jp
Sponsor or person
Institute
Ligua Inc.
Institute
Department
Personal name
Funding Source
Organization
Ligua Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nihonbashi Cloud Clinic, Seiunkai General Incorporated Association
Address
2-16-3 Nihonbashi, Chuo-ku, Tokyo
Tel
050-1808-4537
info@cloud-clinic-nihonbashi.com
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
| 2026 | Year | 11 | Month | 05 | 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
| 2026 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072704
