UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014084 |
|---|---|
| Receipt number | R000016393 |
| Scientific Title | Oral Yokukansan treatment for essential blepharospasm |
| Date of disclosure of the study information | 2014/05/31 |
| Last modified on | 2023/12/04 19:36:10 |
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Basic information
Public title
Oral Yokukansan treatment for essential blepharospasm
Acronym
Yokukansan for blepharospasm
Scientific Title
Oral Yokukansan treatment for essential blepharospasm
Scientific Title:Acronym
Yokukansan for blepharospasm
Region
| Japan |
Condition
Condition
Essential blepharospasm
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of oral Yokukansan for essential blepharospasm.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Grading scale reported by Jankovic
National Eye Institute Visual Functioning Questionnaire 25
Severity of dry eye
Evaluation before and 1 month after the start of treatment.
Key secondary outcomes
Blood test (potassium, Creatinine kinase, liver function)
Evaluation before and 1 month after the start of treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Yokukansan 2.5g x 3/day for 1 month.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged > 20 years.
Key exclusion criteria
Patients who undergo botulinum toxin injection within 3 months.
Poor in health.
Patients who take a medicine containing licorice or glycyrrhizic acid.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Aichi medical University
Division name
Ophthalmology
Zip code
4801195
Address
1-1, Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
cosme@d1.dion.ne.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Aichi medical University
Division name
Ophthalmology
Zip code
4801195
Address
1-1, Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
yasuhiro_tak@yahoo.co.jp
Sponsor or person
Institute
Aichi medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561623311
aichi-med@esct.bvits.com
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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
