UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036344 |
|---|---|
| Receipt number | 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 17:01:15 |
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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
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
takada.ikumi@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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041409
