UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study between the olfactory training methods with the guidance of eating manner for the efficacy in patients with olfactory dysfunction.
Title of the study (Brief title)	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	Hideaki Shiga
Organization	Kanazawa Medical University
Division name	Otorhinolaryngology
Address	1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL	076-218-8147
Email	ent@kanazawa-med.ac.jp

Public contact
Name of contact person	Hideaki Shiga
Organization	Kanazawa Medical University
Division name	Otorhinolaryngology
Address	1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL	076-218-8147
Homepage URL
Email	ent@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 04 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027085