UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023521 |
|---|---|
| Receipt number | R000027085 |
| Scientific Title | Comparative study between the olfactory training methods with the guidance of eating manner for the efficacy in patients with olfactory dysfunction. |
| Date of disclosure of the study information | 2016/08/06 |
| Last modified on | 2017/02/09 09:31:34 |
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Basic information
Public title
Comparative study between the olfactory training methods with the guidance of eating manner for the efficacy in patients with olfactory dysfunction.
Acronym
The olfactory training methods with the guidance of eating manner.
Scientific Title
Comparative study between the olfactory training methods with the guidance of eating manner for the efficacy in patients with olfactory dysfunction.
Scientific Title:Acronym
The olfactory training methods with the guidance of eating manner.
Region
| Japan |
Condition
Condition
olfactory dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We develop the effective olfactory training method to guide the daily eating manner for the treatment in patients with olfactory dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation with T&T olfactometry
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Olfactory training with nasal stimulation of food smell three times a day for 24 weeks
Interventions/Control_2
Olfactory training with oral stimulation of food smell three times a day for 24 weeks
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
1) Patients with olfactory dysfunction.
2) Patients aged 20 years old or more.
3) Gender unquestioned.
4) Outpatient.
5) Patients who have given voluntary written informed consent.
Key exclusion criteria
1) Patients who have food allergy.
2) Patients who are pregnant, suspected to be pregnant or breastfeeding.
3) Patients who desire to bear children
4) Patients who are considered not to be eligible by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Shiga |
Organization
Kanazawa Medical University
Division name
Otorhinolaryngology
Zip code
Address
1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL
076-218-8147
ent@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Shiga |
Organization
Kanazawa Medical University
Division name
Otorhinolaryngology
Zip code
Address
1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL
076-218-8147
Homepage URL
ent@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical 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
Address
Tel
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
| 2016 | Year | 08 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 02 | 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
Altundag et al. Modified olfactory training in patients with postinfectious olfactory loss. Laryngoscope 125:1763-6, 2015.
Management information
Registered date
| 2016 | Year | 08 | Month | 06 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027085
