UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study between Tokisyakuyakusan and mecobalamin for the efficacy in patients with olfactory dysfunction post-respiratory infection.
Acronym	Comparative study between Tokisyakuyakusan and mecobalamin for the efficacy in patients with olfactory dysfunction post-respiratory infection.
Scientific Title	Comparative study between Tokisyakuyakusan and mecobalamin for the efficacy in patients with olfactory dysfunction post-respiratory infection.
Scientific Title:Acronym	Comparative study between Tokisyakuyakusan and mecobalamin for the efficacy in patients with olfactory dysfunction post-respiratory infection.
Region	Japan

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

Objectives
Narrative objectives1	We evaluate the efficacy and the safety of Tokisyakuyakusan or mecobalamin for the treatment in patients with olfactory dysfunction post-respiratory infection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation with T&T olfactometry after the treatment for 24 weeks.
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	Medicine
Interventions/Control_1	Tokisyakuyakusan 7.5g/day 3 times a day, before meals 24 weeks
Interventions/Control_2	Mecobalamin 1500µg/day 3 times a day, after meals 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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with olfactory dysfunction post-respiratory infection who have developed from at least four weeks ago and within less than one year. 2) Patients aged 20 years old or more and 60 years old or less. 3) Gender unquestioned 4) Outpatient 5) Patients with olfactory dysfunction who have odor recognition thresholds by T&T olfactometry as 2.6 and more (moderate or severe dysosmia) 6) Patients who have given voluntary written informed consent.
Key exclusion criteria	1) Patients who have rhinosinusitis which is subjected to effect on olfactory dysfunction post-respiratory infection. 2) Patients who used Tokisyakuyakusan or mecobalamin within the last two weeks (It will be eligible if they do not use those medicine for at least two weeks). 3) Patients who are pregnant, suspected to be pregnant or breastfeeding. 4) Patients who desire to bear children 5) 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 Takaki Miwa
Organization	Kanazawa Medical University
Division name	Otorhinoaryngorogy
Zip code
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	076-286-2211
Email	miwataka@kanazawa-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideaki Shiga
Organization	Kanazawa Medical University
Division name	Otorhinoaryngorogy
Zip code
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	076-286-2211
Homepage URL
Email	shigah@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	Kanazawa Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 13 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	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
Date of IRB	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2021 Year 03 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 13 Day
Last modified on	2022 Year 09 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024225