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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018148
Receipt No. 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

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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
Email 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
Email yokkan3@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Faculty of Medicine
Department of Neurology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020272

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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