UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051490 |
|---|---|
| Receipt number | R000058612 |
| Scientific Title | Effect of atomized chlorous acid water on environmental microbes and human health |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/01/30 18:41:37 |
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Basic information
Public title
Assessment of atomized chlorous acid water on environmental hygienic effect and safety for human health
Acronym
Study of atomized chlorous acid water
Scientific Title
Effect of atomized chlorous acid water on environmental microbes and human health
Scientific Title:Acronym
Study of atomized chlorous acid water
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Medicine in general | Ophthalmology | Dermatology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of atomized chlorous acid water on human health.
Basic objectives2
Others
Basic objectives -Others
To clarify the sanitizing effect of atomized chlorous acid water.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Following clinical findings after 5-day exposure (1 hour/day) to atomized chlorous acid water
1. Blood analysis
2. Chest X-ray examination
3. Keratoconjunctive inflammation
4. Skin inflammation
Key secondary outcomes
Monitoring of environmental bacterial number after atomization of chlorous acid water
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A group exposed to atomized chlorous acid water
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult without underlying disease
Key exclusion criteria
Those with serious underlying diseases (especially allergies and asthma)
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Tamiko |
| Middle name | |
| Last name | Nagao |
Organization
Shikoku University, Junior College
Division name
Department of Science for Human Health Welfare Care Major
Zip code
771-1192
Address
123-1 Ebisuno, Furukawa, Ojin-cho, Tokushima-shi, Tokushima Prefecture
TEL
088-665-9372
tnagao@shikoku-u.ac.jp
Public contact
Name of contact person
| 1st name | Tamiko |
| Middle name | |
| Last name | Nagao |
Organization
Shikoku University, Junior College
Division name
Department of Science for Human Health Welfare Care Major
Zip code
771-1192
Address
123-1 Ebisuno, Furukawa, Ojin-cho, Tokushima-shi, Tokushima Prefecture
TEL
088-665-9372
Homepage URL
tnagao@shikoku-u.ac.jp
Sponsor or person
Institute
Shikoku University, Junior College
Institute
Department
Personal name
Tamiko Nagao
Funding Source
Organization
NSF Engagement Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
PURGATIO Incorporated
SANKEI Company Limited
IRB Contact (For public release)
Organization
Shikoku University Research Ethics Review Committee
Address
123-1 Ebisuno, Furukawa, Ojin-cho, Tokushima-shi, Tokushima Prefecture
Tel
088-665-1300
gakubu-shien@shikoku-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 | 07 | Month | 01 | 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
ABC
Results date posted
| 2024 | Year | 01 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
ABC
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | 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
| 2023 | Year | 06 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058612
