UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040769 |
|---|---|
| Receipt number | R000046559 |
| Scientific Title | A Study on change of the olfactory sensitivity |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/12/09 14:54:48 |
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Basic information
Public title
A Study on change of the olfactory sensitivity
Acronym
A Study on change of the olfactory sensitivity
Scientific Title
A Study on change of the olfactory sensitivity
Scientific Title:Acronym
A Study on change of the olfactory sensitivity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Oto-rhino-laryngology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the changes of olfactory sensitivity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of olfactory sensitivity
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Clean the tongue once a day for 2 weeks using a tongue brush
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
-Subjects who hospitalized or taking medication for chronic diseases (diabetes, heart / kidney / liver disease, congenital heart disease)
-Subjects with disease in nose
-Subjects who dislike perfume, or other odor substances
-Subjects who are hypersensitive to chemicals
-Subjects who are undergoing a hormone replace therapy
-The pregnant and potentially pregnant, subjects in nursing
-Subjects with an infectious disease
-Subjects who take an antibiotics from 3 weeks before the screening test
-Subjects with obvious intraoral injury
-Subjects who are attending a dental clinic and receiving oral treatment
-Subjects who are cleaning their tongue everyday
-Subjects who cannot suspend tongue cleaning from the acquisition date of informed consent
-Subjects with smoking habit
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sakamoto |
Organization
Kao Corporation
Division name
Sensory Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7682
sakamoto.takashi@kao.com
Public contact
Name of contact person
| 1st name | Chisaki |
| Middle name | |
| Last name | Uehara |
Organization
Kao Corporation
Division name
Sensory Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7682
Homepage URL
uehara.chisaki@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
+81-3-5630-7263
morisaki.naoko@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
| 2020 | Year | 06 | 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
150
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
| 2020 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046559
