UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022108 |
|---|---|
| Receipt number | R000025209 |
| Scientific Title | Is olfactory stimulation effective on olfactory recovery? |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2016/11/02 18:17:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Is olfactory stimulation effective on olfactory recovery?
Acronym
Is olfactory stimulation effective on olfactory recovery?
Scientific Title
Is olfactory stimulation effective on olfactory recovery?
Scientific Title:Acronym
Is olfactory stimulation effective on olfactory recovery?
Region
| Japan |
Condition
Condition
Olfactory dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether olfactory stimulation is effective on olfactory recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Results of T&T olfactometry and Open Essence tests.(Every three months)
Key secondary outcomes
Symptoms of patients.(Every three months)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Chemicals used for olfactory training should keep vaporizing odor for 3 months without degradation or decay. As familiar odors to Japanese people, we selected Vanilla, Yuzu, Peach, Caramel, Rose, and Lemon for olfactory training.
We put 10 ml of these odorous chemicals each in brown glass vial bottles. A piece of cotton wool is inserted for absorbing chemicals. The training kit include 4 bottles in a plastic case.
Patients are asked to sniff these odors for 15 seconds by twice. Every day they are instructed to do training twice or three times a day.
Chemicals used for olfactory training were changed at October, 2016. Now we use flavors of Coffee, Blueberry, Pineapple, and Peppermint.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with olfactory dysfunction due to after infection or head trauma.
Key exclusion criteria
Patients without enough recognition ability to do olfactory training.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumino Okutani |
Organization
Kochi Medical School
Division name
Department of Occupational Health,
Zip code
Address
Nankoku, Kochi 783-8505
TEL
088-880-2560
okutanif@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumino Okutani |
Organization
Kochi Medical School
Division name
Department of Occupational Health,
Zip code
Address
Nankoku, Kochi 783-8505
TEL
088-880-2560
Homepage URL
okutanif@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Kochi 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
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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 27 | 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
Date of protocol fixation
| 2016 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025209
