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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028396
Receipt No. R000032509
Scientific Title Effects of Goreisan for wheather-related primary headache
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/27

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Basic information
Public title Effects of Goreisan for wheather-related primary headache
Acronym Effects of Goreisan for wheather-related primary headache
Scientific Title Effects of Goreisan for wheather-related primary headache
Scientific Title:Acronym Effects of Goreisan for wheather-related primary headache
Region
Japan

Condition
Condition Primary headache
Classification by specialty
Medicine in general Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between wheather condition and headache.
Basic objectives2 Others
Basic objectives -Others To examine the effects of Goreisan for wheather-related primary headache.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Headache days
Key secondary outcomes Medication days

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 To prescribe Goreisan 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

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects must satisfy the following conditions for inclusion:
1.Primary headache
2.Understand the explanation of the experiment and express consent.
Key exclusion criteria 1. Change of preventive medication for headache within half year.
2. Past history of side effects of herbs medicine.
3. Perticipating another clinical trials
4. Judgement as unappropriate for the persification into this clinical trial.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Shibata
Organization Department of Neurosurgery, Headache Clinic, University of Tsukuba, Mito medical center, Mito kyodo general hospital.
Division name Neurosurgery/Headache Clinic
Zip code
Address 3-2-7 miyamachi, Mito, Ibaraki
TEL 029-231-2371
Email yshibata@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sumire Ishiyama
Organization University of Tsukuba
Division name Graduate School of Comprehensive Human Sciences, Doctoral Program in Clinical Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-231-2371
Homepage URL
Email ckckck_sumire@yahoo.co.jp

Sponsor
Institute University of Tsukuba, Mito medical center, Mito kyodo general hospital.
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 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
Results
Results date posted
Results Delayed
Results Delay Reason
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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 27 Day
Last modified on
2017 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032509

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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