UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049124 |
|---|---|
| Receipt number | R000055228 |
| Scientific Title | Confirmation of the effect of reducing pollen symptoms by removing pollen using the pollen countermeasure space and suppressing the action of pollen allergens |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/04/01 00:12:11 |
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Basic information
Public title
Confirmation of the effect of reducing pollen symptoms by removing pollen using the pollen countermeasure space and suppressing the action of pollen allergens
Acronym
Confirmation of the effect of reducing pollen symptoms by removing pollen using the pollen countermeasure space and suppressing the action of pollen allergens
Scientific Title
Confirmation of the effect of reducing pollen symptoms by removing pollen using the pollen countermeasure space and suppressing the action of pollen allergens
Scientific Title:Acronym
Confirmation of the effect of reducing pollen symptoms by removing pollen using the pollen countermeasure space and suppressing the action of pollen allergens
Region
| Japan |
Condition
Condition
allergy to pollen
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of reducing pollinosis symptoms in a pollinosis countermeasure space that combines an air shower with static electricity removal function and a photocatalytic coating
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire survey on changes in pollinosis symptoms before and after staying
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Exposure of air shower with static electricity removal function.
Living in a living room with photocatalytic coating (17 hours)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who have symptoms of allergy to pollen at a fixed time every year
Persons who have no health problems
Person who obtained consen in explanation / consent document
Key exclusion criteria
Persons who are judged to be inappropriate by the principal investigator or the research coordinator
When symptoms such as mood discomfort appear during verification in the pollinosis countermeasure space
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Umeda |
Organization
Nara Medical University
Division name
MBT Laboratory
Zip code
6348521
Address
840 Shijo-cho, Kashihara-shi, Nara
TEL
0744223051
umeda@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomhiro |
| Middle name | |
| Last name | Umeda |
Organization
Nara Medical University
Division name
MBT Laboratory
Zip code
6348521
Address
840 Shijo-cho, Kashihara-shi, Nara
TEL
0744223051
Homepage URL
umeda@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Daiwa House Industry 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
Nara Medical University
Address
840 Shijo-cho, Kashihara-shi, Nara
Tel
0744223051
umeda@naramed-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 | 03 | Month | 31 | 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
88
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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055228
