UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018148 |
|---|---|
| Receipt number | R000020272 |
| Scientific Title | The effect of Yokukansan on medication overuse headache |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2019/03/27 10:48:27 |
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Basic information
Public title
The effect of Yokukansan on medication overuse headache
Acronym
The effect of Yokukansan on medication overuse headache
Scientific Title
The effect of Yokukansan on medication overuse headache
Scientific Title:Acronym
The effect of Yokukansan on medication overuse headache
Region
| Japan |
Condition
Condition
Medication Overuse Headache
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Yokukansan on medication overuse headaches
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of headache days
Number of migraine attacks
Key secondary outcomes
Intensity of headache(VAS score)
Intensity of anxiety(Hamilton AnxietyScale)
Intensity of irritation
HIT6
Questionnaire for Kanpo Medicine
Number of tablets for acute medicine
Laboratory test
Side effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TJ-54 Tsumura Yokukansan 7.5g/day
8weeks
Interventions/Control_2
Placebo 7.5g/day
8weeks
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
headache days >20days/month
headache type: migraine
serum potassium level before the start of treatment within 4 weeks should be in normal range
Key exclusion criteria
experience of taking yokukansan
taking other Kampo-medicine
having severe cardiac disease, liver disease, kidney disease, hematologic disorders, lung disease, or other severe disease related to life itself
having psychological disorders such as depression or other disorders due to DSM-5
unable to take oral medicine
under treatment of acupuncture, chiropractic, massage
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Araki |
Organization
Saitama Medical University Faculty of Medicine
Division name
Department of Neurology
Zip code
3500495
Address
38 Morohongo Moroyama-machi Iruma-gun Saitama
TEL
049-276-1209
yokkan3@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Hirayama |
Organization
Saitama Medical University Faculty of Medicine
Division name
Department of Neurology
Zip code
3500495
Address
38 Morohongo Moroyama-machi Iruma-gun Saitama
TEL
049-276-1209
Homepage URL
yokkan3@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Faculty of Medicine
Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Saitama Medical University Hospital Institutinal Review Board
Address
38Morohongou,Moroyama-machi,Saitama
Tel
049-276-1354
hirb@saitama-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
埼玉医科大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 01 | 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
85
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because key opening was lated.
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 | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020272
