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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040376
Receipt No. R000044791
Scientific Title Effectiveness of Japanese version of olfactory training
Date of disclosure of the study information 2020/06/01
Last modified on 2021/05/13

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Basic information
Public title Effectiveness of Japanese version of olfactory training
Acronym Japanese olfactory training
Scientific Title Effectiveness of Japanese version of olfactory training
Scientific Title:Acronym Effectiveness of Japanese version of olfactory training
Region
Japan

Condition
Condition olfactory dysfunction patient
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effectiveness of olfactory training in Japanese population and whether odor would be the factor of its effetiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the scores of questionnaire which assess the patient's symptom and olfactory test score between before and after 12 weeks olfactory training.
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 4
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 12 weeks olfactory training (Original method which is reported abroad)
Interventions/Control_2 12 weeks olfactory training (with the familiar odors for Japanese)
Interventions/Control_3 12 weeks olfactory training (with the non-familiar odors for Japanese)
Interventions/Control_4 Only ordinary medication group
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 Post infectious olfactory dysfunction
Post - traumatic olfactory dysfunction
Key exclusion criteria Sinusitis
Neurodegenerative disease
Target sample size 100

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 113-8603
Address Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email 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 113-8603
Address Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email yoshinoayaho@nms.ac.jp

Sponsor
Institute Nippon medical school
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
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
Email 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 日本医科大学付属病院

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 01 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
2020 Year 05 Month 01 Day
Date of IRB
2020 Year 09 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
2021 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044791

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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