Tokyo, May 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061550) titled 'Clinical quantitative analysis of Gosyuyutou and acute and preventive medication for the patient with migraine' on May 13.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - University of Tsukuba, Mito Medical Center, Mito Kyodo General Hospital
Condition:
Condition - migraine
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - oral intake of Gosyuyuto
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070224
Disclaimer: Curated by HT Syndication.
