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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036344
Receipt No. R000041409
Scientific Title Evaluation of effects of volatile materials on biological functions
Date of disclosure of the study information 2019/04/15
Last modified on 2019/09/04

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Basic information
Public title Evaluation of effects of volatile materials on biological functions
Acronym Evaluation of effects of volatile materials on biological functions
Scientific Title Evaluation of effects of volatile materials on biological functions
Scientific Title:Acronym Evaluation of effects of volatile materials on biological functions
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of volatile materials on immune function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Indicators of immune function; ex)activity of immune cells, mucociliary activity
Key secondary outcomes Nasal airway resistance value

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 exposure to volatile material A (10 minutes)->wash out (3 days)->exposure to volatile material B (10 minutes)->wash out (3 days)->exposure to volatile material C (10 minutes)->wash out (3 days)
Interventions/Control_2 exposure to volatile material A (10 minutes)->wash out (3 days)->exposure to volatile material C (10 minutes)->wash out (3 days)->exposure to volatile material B (10 minutes)->wash out (3 days)
Interventions/Control_3 exposure to volatile material B (10 minutes)->wash out (3 days)->exposure to volatile material C (10 minutes)->wash out (3 days)->exposure to volatile material A (10 minutes)->wash out (3 days)
Interventions/Control_4 exposure to volatile material B (10 minutes)->wash out (3 days)->exposure to volatile material A (10 minutes)->wash out (3 days)->exposure to volatile material C (10 minutes)->wash out (3 days)
Interventions/Control_5 exposure to volatile material C (10 minutes)->wash out (3 days)->exposure to volatile material A (10 minutes)->wash out (3 days)->exposure to volatile material B (10 minutes)->wash out (3 days)
Interventions/Control_6 exposure to volatile material C (10 minutes)->wash out (3 days)->exposure to volatile material B (10 minutes)->wash out (3 days)->exposure to volatile material A (10 minutes)->wash out (3 days)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male
Key inclusion criteria Healthy men
Key exclusion criteria -Subjects with chronic nasal disease
-Subjects with nasal scratch
-Subjects with severe disease
-Subjects to go to hospital or to take medicines for treatment.
-Subjects to participate in research or treatment with effects on this study
-Subjects with skin trouble by alcohol
-Subjects with claustrophobia
-Smokers
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Mori
Organization Kao Corporation
Division name Biological Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7440
Email mori.takuya@kao.com

Public contact
Name of contact person
1st name Ikumi
Middle name
Last name Takada
Organization Kao Corporation
Division name Biological Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7440
Homepage URL
Email takada.ikumi@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 Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-9220
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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 15 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 25
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
2019 Year 03 Month 22 Day
Date of IRB
2019 Year 03 Month 22 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2019 Year 07 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 09 Month 04 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 29 Day
Last modified on
2019 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041409

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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