UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045757 |
|---|---|
| Receipt number | R000052240 |
| Scientific Title | Characteristics of dizziness for which chotosan is effective |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2024/04/17 15:53:40 |
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Basic information
Public title
Characteristics of dizziness for which chotosan is effective
Acronym
Dizziness for which chotosan is effective
Scientific Title
Characteristics of dizziness for which chotosan is effective
Scientific Title:Acronym
Dizziness for which chotosan is effective
Region
| Japan |
Condition
Condition
dizziness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the characteristics of dizziness for which chotosan is effective
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
difference in efficacy rate due to exacerbation factors
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who administered chotosan for dizziness
2)Age and Gender do not matter
3)Patients who were able to followed up the course after use
Key exclusion criteria
1)Patients who discontinued use chotosan due to adverse events and so on
2)Patients who were not able to followed up the course after use
3)Patients who have offered to not participate in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Hirasawa |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Otorhinolaryngology
Zip code
300-0395
Address
3-20-1 Chuo, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-887-1161
hirakazu@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Hirasawa |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Otorhinolaryngology
Zip code
300-0395
Address
3-20-1 Chuo, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-887-1161
Homepage URL
hirakazu@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Medical University Medical Ethics Review Board
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
Adm_IRB@tokyo-med.ac.jp
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
東京医科大学茨城医療センター(茨城県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000045757
Publication of results
Published
Result
URL related to results and publications
https://seronjihou.files.wordpress.com/2022/04/292105.pdf
Number of participants that the trial has enrolled
26
Results
The proportion of cases in which dizziness was induced by head rotation or extension in the standing position was 75 % (12 cases) in the effective group and 10 % (one case) in the ineffective group. Therefore, it was higher in the effective group (p=0.002).
Results date posted
| 2021 | Year | 10 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A case in which chotosan was administered at Tokyo Medical University Ibaraki Medical Center
Participant flow
1)A case in which chotosan was administered for dizziness
2)Age and gender are not required
3)Cases with follow-up after use
Adverse events
Nothing particular
Outcome measures
difference in efficacy rate due to exacerbation factors
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Comparison of effective group and ineffective group
Management information
Registered date
| 2021 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052240
