UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049682 |
|---|---|
| Receipt number | R000055500 |
| Scientific Title | Research on the application of aroma sticks to olfactory testing |
| Date of disclosure of the study information | 2022/12/08 |
| Last modified on | 2024/06/04 11:03:16 |
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Basic information
Public title
Research on the application of aroma sticks to olfactory testing
Acronym
Research on the application of aroma sticks to olfactory testing
Scientific Title
Research on the application of aroma sticks to olfactory testing
Scientific Title:Acronym
Research on the application of aroma sticks to olfactory testing
Region
| Japan |
Condition
Condition
Olfactory dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the use of aromatic sticks as a screening test for olfactory disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To confirm that the correlation between the olfactory test with the aromatic stick and the T&T olfactory test is significant.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Olfactory outpatients and healthy volunteers
Key exclusion criteria
Persons with abnormal language function
Persons with congenital olfactory impairment
Persons with neuropsychiatric disorders
Persons with chemical sensitivity
Other patients deemed unsuitable as subjects by the principal investigator
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Ishimaru |
Organization
Jijunkai Hyotan-machi ENT Clinic
Division name
Otolaryngology
Zip code
92000845
Address
Hyotan-machi 2-13, Kanazawa, Ishikawa
TEL
+81762311958
ta-ishi@kma.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Ishimaru |
Organization
Jijunkai Hyotan-machi ENT Clinic
Division name
Otolaryngology
Zip code
92000845
Address
Hyotan-machi 2-13, Kanazawa, Ishikawa
TEL
+81762311958
Homepage URL
ta-ishi@kma.jp
Sponsor or person
Institute
Jijunkai Hyotan-machi ENT Clinic
Institute
Department
Personal name
Funding Source
Organization
Jijunkai Hyotan-machi ENT Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ishikawa Medical Association
Address
Kuratsukihigashi, 2-48, Kanazawa, Ishikawa
Tel
076-239-3800
kosaka@ishikawa.med.or.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
医）耳順会 ひょうたん町耳鼻咽喉科医院（石川県
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
http://www.hyotan-machi.com/protocol/aromastic/aromastic.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0385814623002018?via%3Dihub
Number of participants that the trial has enrolled
40
Results
The aromastic-scores and T&T olfactometry detection and recognition thresholds showed significant correlations, confirming that the AS-test is a valid olfactory test.
Results date posted
| 2024 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants who had visited an outpatient olfactory clinic were included.
Participant flow
Aromastic test and T&T olfactmetry were performed after imformed concent.
Adverse events
none
Outcome measures
Relationship between AROMASTIC test and T&T olfactmetry
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 26 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 26 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 15 | Day |
Other
Other related information
The study period was extended due to COVID19.
Management information
Registered date
| 2022 | Year | 12 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055500
