UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039909 |
|---|---|
| Receipt number | R000044246 |
| Scientific Title | Development of an odor test for children considering language development |
| Date of disclosure of the study information | 2020/03/24 |
| Last modified on | 2020/03/23 14:25:22 |
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Basic information
Public title
Development of an odor test for children considering language development
Acronym
odor test for children
Scientific Title
Development of an odor test for children considering language development
Scientific Title:Acronym
odor test for children
Region
| Japan |
Condition
Condition
ASD
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop an odor test for Japanese children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSIT-J
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Normal/30 minutes once
Interventions/Control_2
ASD/30 minutes once
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
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A child whose parental consent has been obtained.
Key exclusion criteria
Non
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuna |
| Middle name | |
| Last name | Inada |
Organization
Kanazawa University
Division name
Institute of Liberal Arts and Science
Zip code
9201192
Address
Kakuma-machi, Kanazawa, Ishikawa
TEL
0762645813
yunainada@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuna |
| Middle name | |
| Last name | Inada |
Organization
Kanazawa University
Division name
Institute of Liberal Arts and Science
Zip code
9201192
Address
Kakuma-machi, Kanazawa, Ishikawa
TEL
0762645813
Homepage URL
yunainada@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1,Takara machi, Kanazawa, Ishikawa
Tel
076-265-2049
crc.irb-knz@esct.jp
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
| 2020 | Year | 03 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044246
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
