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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043584
Receipt No. R000049765
Scientific Title Imaging study on the efficacy of Chinese herbal medicine for migraine and primary headache induced by pressure change
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/11

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Basic information
Public title Image study of the effect of Chinese herbal medicine on migraine and headache caused by pressure change
Acronym Research on Chinese Herbal Medicine for headache
Scientific Title Imaging study on the efficacy of Chinese herbal medicine for migraine and primary headache induced by pressure change
Scientific Title:Acronym Image study of Chinese herbal medicine for primary headache
Region
Japan

Condition
Condition Migraine, headache due to pressure change
Classification by specialty
Medicine in general Neurology Radiology
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There are no studies on the therapeutic effects of Chinese herbal medicines in terms of imaging, so we will examine the microstructure and brain function of these medicines.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Microstructure and brain functional connectivity in the treatment-responsive group after 2 months of oral medication
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients will first undergo rsfMRI, DTI, NODDI, T1 sagittal, and FLAIR imaging. After that, patients with migraine headache are started on Gosyuyuto and those with barometric headache are started on Goreisan.Two months after the start of medication, imaging will be performed again with the same protocol.
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Subjects with a history of migraine or headache due to pressure change who understood the purpose of this study and gave consent
Key exclusion criteria (1) Having an underlying disease and receiving treatment
(2) Already taking Kampo medicines (Gosyuyuto, Goreisan or other)
(3) During pregnancy
(4) Currently participating or planning to participate in other clinical trials
(5) Claustrophobia
(6) Unsuitable for MRI imaging such as pacemaker or implant
(7) Having been judged by the physician in charge to be inappropriate for participation in this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yasushi
Middle name
Last name Shibata
Organization University of Tsukuba
Mito Kyodo General Hospital
Division name Neurosurgery
Zip code 310-0015
Address 3-2-7, Miyamachi, Mito city, Ibaraki prefecture, Japan
TEL 029-231-2371
Email yshibata@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Yasushi
Middle name
Last name Shibata
Organization Mito Kyodo General Hospital
Division name Neurosurgery
Zip code 310-0015
Address 3-2-7, Miyamachi, Mito city, Ibaraki prefecture, Japan
TEL 029-231-2371
Homepage URL
Email yshibata@md.tsukuba.ac.jp

Sponsor
Institute Mito Kyodo General Hospital
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Mito Kyodo General Hospital
Address 3-2-7, Miyamachi, Mito city, Ibaraki prefecture, Japan
Tel 029-231-2371
Email yshibata@md.tsukuba.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

Other administrative information
Date of disclosure of the study information
2021 Year 04 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 Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 31 Day
Date of IRB
2021 Year 03 Month 04 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 11 Day
Last modified on
2021 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049765

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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