UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061550 |
|---|---|
| Receipt number | R000070224 |
| Scientific Title | Clinical quantitative analysis of Gosyuyutou and acute and preventive medication for the patient with migraine |
| Date of disclosure of the study information | 2026/05/13 |
| Last modified on | 2026/05/13 11:43:18 |
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Basic information
Public title
Clinical quantitative analysis of Gosyuyutou and acute and preventive medication for the patient with migraine
Acronym
Clinical quantitative analysis of Gosyuyutou and acute and preventive medication for the patient with migraine
Scientific Title
Clinical quantitative analysis of Gosyuyutou and acute and preventive medication for the patient with migraine
Scientific Title:Acronym
Clinical quantitative analysis of Gosyuyutou and acute and preventive medication for the patient with migraine
Region
| Japan |
Condition
Condition
migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prevalence of migraine in Japan is approximately 8%, indicating a very large patient population. Numerous Western medicines are available for both acute and preventive treatment of migraine, and most of them have undergone scientific comparison with placebo in phase III multicenter clinical trials. Only those that demonstrated statistically significant efficacy have been approved and marketed.
Goshuyuto, a traditional Kampo formula, is also prescribed for migraine; however, it has not been evaluated using clinical trial standards equivalent to those applied to Western medicines. To enable a valid comparison with Western drugs, assessment based on the same criteria is essential.
In this study, we will quantitatively evaluate the effects of Goshuyuto at three time points: during acute attacks, for prevention, and at the onset of prodromal symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute Treatment Arm: For acute treatment, patients will take one packet (2.5 g) of Goshuyuto within one hour after migraine onset. The primary endpoints are headache resolution or improvement at 2 hours after administration, as well as adverse events. These will be self evaluated by patients and recorded on study-specific forms. Secondary endpoints include headache resolution or improvement at 1 hour, adverse events occurring after 2 hours, same day headache recurrence, and the need for additional medication. Each patient will record three migraine attacks.
Preventive Treatment Arm: For preventive therapy, patients will take one packet (2.5 g) of Goshuyuto three times daily, in principle before meals. Treatment will be continued for at least three months, during which patients will complete a headache diary. Monthly headache days, adverse events, HIT 6 scores, and medication adherence will be aggregated. If treatment is discontinued within three months, data up to the point of discontinuation will be analyzed, and the reason for discontinuation will be documented. For patients who continue treatment beyond three months, the study will transition into a long-term extension phase, and monthly headache days, adverse events, HIT-6 scores, and other outcomes will be collected whenever possible. Data from patients who discontinue during the long-term phase will also be aggregated to evaluate the impact of discontinuation.
Prodrome-Triggered Treatment Arm: For prodrome-triggered use, patients will take the medication when they perceive prodromal symptoms. Improvement or resolution of prodromal symptoms at 1 and 2 hours after administration, as well as the preventive effect on subsequent headache attacks, will be evaluated. Patients will record prodromal symptoms and outcomes on designated forms.
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
oral intake of Gosyuyuto
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with migraine by a headache specialist according to the International Classification of Headache Disorders, 3rd edition (ICHD 3), whose attending physician judges them to have kyo sho (deficiency pattern), and who consent to taking Goshuyuto, undergoing its evaluation, completing a headache diary, and participating in the study will be included. There are no restrictions on age or sex.
For the preventive arm, only patients with at least 2 months of headache diary data before treatment initiation will be eligible. For the prodrome-triggered arm, only patients who are able to recognize prodromal symptoms will be included. Prodromal symptoms are defined as photophobia, phonophobia, osmophobia, fatigue, dizziness, and similar manifestations.
Key exclusion criteria
Patients whom the attending physician judges to be inappropriate for participation in this study will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Division name
Department of Neurosurgery/Headache Clinic
Zip code
3100015
Address
Mito, Ibaraki, 310-0015, Japan
TEL
0292312371
yshibata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Division name
Department of Neurosurgery/Headache Clinic
Zip code
3100015
Address
Mito, Ibaraki, 310-0015, Japan
TEL
029231-2371
Homepage URL
yshibata@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
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
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Address
Mito, Ibaraki, 310-0015, Japan
Tel
0292312371
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
| 2026 | Year | 05 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070224
