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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014084
Receipt No. R000016393
Official scientific title of the study Oral Yokukansan treatment for essential blepharospasm
Date of disclosure of the study information 2014/05/31
Last modified on 2016/11/27

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Basic information
Official scientific title of the study Oral Yokukansan treatment for essential blepharospasm
Title of the study (Brief title) 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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Hirohiko Kakizaki
Organization Aichi medical University
Division name Ophthalmology
Address 1-1, Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561-62-3311
Email cosme@d1.dion.ne.jp

Public contact
Name of contact person Yasuhiro Takahashi
Organization Aichi medical University
Division name Ophthalmology
Address 1-1, Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561-62-3311
Homepage URL
Email yasuhiro_tak@yahoo.co.jp

Sponsor
Institute Aichi medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2014 Year 05 Month 27 Day
Anticipated trial start date
2014 Year 06 Month 02 Day
Last follow-up date
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

Management information
Registered date
2014 Year 05 Month 27 Day
Last modified on
2016 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016393


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