UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Is olfactory stimulation effective on olfactory recovery?
Title of the study (Brief title)	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	Fumino Okutani
Organization	Kochi Medical School
Division name	Department of Occupational Health,
Address	Nankoku, Kochi 783-8505
TEL	088-880-2560
Email	okutanif@kochi-u.ac.jp

Public contact
Name of contact person	Fumino Okutani
Organization	Kochi Medical School
Division name	Department of Occupational Health,
Address	Nankoku, Kochi 783-8505
TEL	088-880-2560
Homepage URL
Email	okutanif@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 01 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025209