UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060449 |
|---|---|
| Receipt number | R000069165 |
| Scientific Title | Effects on Physical Condition from Using Plasma Irradiation Equipments : single blinded study |
| Date of disclosure of the study information | 2026/01/23 |
| Last modified on | 2026/01/23 16:00:22 |
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Basic information
Public title
Effects on Physical Condition from Using Plasma Irradiation Equipment
Acronym
Plasma study
Scientific Title
Effects on Physical Condition from Using Plasma Irradiation Equipments : single blinded study
Scientific Title:Acronym
Effects on Physical Condition from Using Plasma Irradiation Equipment
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects on Physical Condition from Using Plasma Irradiation Equipment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva test, questionnaire
Key secondary outcomes
blood flow/blood pressure/pulse measurement, body temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For 5 days, receive 30 minutes of plasma irradiation per day using Test Article A.
Interventions/Control_2
For 5 days, receive 30 minutes of plasma irradiation per day using Test Article B.
Interventions/Control_3
For 5 days, receive 30 minutes of plasma irradiation per day using Test Article C.
Interventions/Control_4
Maintain your usual daily routine for 5 days.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who frequently feel tired in daily life or experience a noticeable tendency to tire easily
Subjects who feel they catch colds more easily or experience more frequent health setbacks
Subjects who do not consider their sleep quality perfect or are dissatisfied with it
Subjects who can maintain their daily routine prior to this trial throughout the trial period
Subjects who can arrive on time and participate for 5 consecutive days
Subjects able to drink the provided 1.0L of water daily
Subjects meeting all of the above conditions
Key exclusion criteria
Pregnant or breastfeeding individuals
Subjects currently receiving treatment or prescriptions for chronic fatigue or chronic fatigue syndrome
Subjects suffering from serious illnesses
Subjects undergoing treatment under a physician's supervision (e.g., hormone replacement therapy, drug therapy, exercise therapy, dietary therapy)
Subjects taking supplements, functional foods, or medications that affect the immune system
Subjects who plan to take or are taking supplements, functional foods, or medications that affect immunity, sleep, body fat, or skin health during the trial period
Subjects with food allergies
Subjects with a history of drug dependence
Subjects with alcohol dependence or who are heavy smokers
Subjects who wish to receive or plan to receive vaccinations within 30 days prior to the trial start date or during the trial period
Subjects working night shifts or rotating day-night shifts
Subjects who have participated in another clinical trial within the past month or plan to participate during this trial period
Other individuals deemed inappropriate by the responsible physician
Target sample size
32
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
ATP Salus laboratory Inc.
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
| 2026 | Year | 01 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 30 | 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 | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069165
