UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021006 |
|---|---|
| Receipt number | R000024225 |
| Scientific Title | Comparative study between Tokisyakuyakusan and mecobalamin for the efficacy in patients with olfactory dysfunction post-respiratory infection. |
| Date of disclosure of the study information | 2016/02/13 |
| Last modified on | 2022/09/29 08:36:04 |
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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
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
shigah@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024225
