UMIN-CTR Clinical Trial

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
Last 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
1st 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