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

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 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

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

Value
https://center6.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