UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043584 |
|---|---|
| Receipt number | 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 | 2024/04/12 15:50:47 |
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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
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
yshibata@md.tsukuba.ac.jp
Sponsor or person
Institute
Mito Kyodo General Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049765
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
