migraine
Conditions
Interventions
oral intake of Gosyuyuto
Sponsors
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Patients whom the attending physician judges to be inappropriate for participation in this study will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYasushi Shibata
University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital Department of Neurosurgery/Headache Clinic
Outcome results
None listed