UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040379 |
|---|---|
| Receipt number | R000046080 |
| Scientific Title | Japanese version of the method for assessment of retronasal olfactory function |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2023/11/30 17:31:00 |
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Basic information
Public title
Japanese version of the method for assessment of retronasal olfactory function
Acronym
Japanese version of the method for assessment of retronasal olfactory function
Scientific Title
Japanese version of the method for assessment of retronasal olfactory function
Scientific Title:Acronym
Japanese version of the method for assessment of retronasal olfactory function
Region
| Japan |
Condition
Condition
olfactory dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the method of retronasal olfactory function using flavor powders in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the validity of the method of retronasal olfactory dysfunction.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
To compare the olfactory dysfunction patients and healthy control
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Olfactory dysfunction patients or healthy volunteer with no olfactory dysfunction
Key exclusion criteria
pregnant or lactating women, people who have food allergy or food intake regulation due to religious or health condition.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Ayaho |
| Middle name | |
| Last name | Yoshino |
Organization
Nippon Medical school
Division name
Oto rhino laryngology
Zip code
113-8602
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
yoshinoayaho@nms.ac.jp
Public contact
Name of contact person
| 1st name | Ayaho |
| Middle name | |
| Last name | Yoshino |
Organization
Nippon Medical school
Division name
Oto rhino laryngology
Zip code
113-8602
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
yoshinoayaho@nms.ac.jp
Sponsor or person
Institute
Nippon Medical school
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical school
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon medical school
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
Tel
03-3822-2131
yoshinoayaho@nms.ac.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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
41
Results
19 healthy controls and 32 olfactory dysfunction patients were enrolled in this study. Retronasal odor identification function was assessed with oral taste powders. Validity analysis revealed that the 13 taste powders differentiated between normosmic participants and olfactory dysfunction patients.
Based on our findings, we advocate 10 points of taste powders test as the cut-off point between patients and controls.
Results date posted
| 2023 | Year | 11 | Month | 30 | Day |
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 30 | 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 | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046080
