UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031918 |
|---|---|
| Receipt number | R000036447 |
| Scientific Title | A parallel group study about the influence which warmed humidification has on nasal mucosa in healthy adult |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/03/28 17:17:00 |
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Basic information
Public title
A parallel group study about the influence which warmed humidification has on nasal mucosa in healthy adult
Acronym
Study about the influence which heated humidification has on nasal mucosa
Scientific Title
A parallel group study about the influence which warmed humidification has on nasal mucosa in healthy adult
Scientific Title:Acronym
Study about the influence which heated humidification has on nasal mucosa
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The fundamental knowledge about the infection prevention and environmental normalization by the heated humidification to a nasal cavity is acquired.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Qualitative and quantitive analysis of the bacteria in nasal mucus
Key secondary outcomes
Quantitive analysis of antimicrobial peptide and evaluation of antimicrobial activity in nasal mucus
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The humidification cup A is applied twice per day while two weeks
Interventions/Control_2
The humidification cup B is applied twice per day while two weeks
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1)The healthy man who detects specific bacteria from nasal mucus
Key exclusion criteria
1)Subjects who have a skin disorder to the test product wearing part
2)Subjects who have the skin allergy condition over drugs, cosmetics, a commercial mask, and warm temperature
3)Subjects who have merged diabetes mellitus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideshi Oda |
Organization
Kao Corporation
Division name
Personal Health Care Products Research
Zip code
Address
2-1-3, Bunka Sumida-ku, Tokyo
TEL
03-5630-7271
oda.hideshi@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigemi Tsuchiya |
Organization
Kao Corporation
Division name
Personal Health Care Products Research
Zip code
Address
2-1-3, Bunka Sumida-ku, Tokyo
TEL
03-5630-7271
Homepage URL
tsuchiya.shigemi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Address
Tel
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
| 2018 | Year | 04 | 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
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
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036447
