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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036515
Receipt No. R000041603
Scientific Title A cross-over study about the influence which warmed humidification has on nasal cavity in healthy adult
Date of disclosure of the study information 2019/05/01
Last modified on 2019/04/15

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Basic information
Public title A cross-over study about the influence which warmed humidification has on nasal cavity in healthy adult
Acronym Study about the influence which heated humidification has on nasal cavity
Scientific Title A cross-over study about the influence which warmed humidification has on nasal cavity in healthy adult
Scientific Title:Acronym Study about the influence which heated humidification has on nasal cavity
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 Evaluation of ciliary activity by saccharin test
Key secondary outcomes Amount analysis of viable bacteria at epipharynx mucus

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 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Treatment A (Wash out period) Treatment B (Wash out period) Treatment C
Interventions/Control_2 Treatment B (Wash out period) Treatment C (Wash out period) Treatment A
Interventions/Control_3 Treatment C (Wash out period) Treatment A (Wash out period) Treatment B
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 The healthy man who do not show allergy-like reaction in a saccharin test (screening stage)
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 Hideshi
Middle name
Last name Oda
Organization Kao corporation
Division name Personal health Care Products Research
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7271
Email oda.hideshi@kao.com

Public contact
Name of contact person
1st name Shigemi
Middle name
Last name Tsuchiya
Organization Kao corporation
Division name Personal Health Care Products Research
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7272
Homepage URL
Email tsuchiya.shigemi@kao.com

Sponsor
Institute Kao corporation
Institute
Department

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 Kao corporation
Address 2-1-3 Bunka Sumida-ku Tokyo
Tel 03-5630-9220
Email uesaka.toshio@kao.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
2019 Year 05 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 39
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 No longer recruiting
Date of protocol fixation
2019 Year 03 Month 04 Day
Date of IRB
2019 Year 03 Month 07 Day
Anticipated trial start date
2019 Year 03 Month 25 Day
Last follow-up date
2019 Year 06 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041603

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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