Episodic Migraine
Conditions
Keywords
Episodic migraine, Gou-Teng-San, Gou Teng San, Choto-san
Brief summary
The goal of this study is to learn whether Gou-Teng-San (GTS), a traditional herbal medicine, is effective and safe for adults with episodic migraine. In this double-blind randomized controlled trial, participants with episodic migraine will be assigned by chance to a study treatment group. The study will evaluate whether GTS can reduce migraine frequency, improve migraine-related symptoms, and lessen the impact of migraine on daily life. Researchers will also monitor safety and tolerability throughout the study.
Interventions
DRUGGou-Teng-San
Participants in this arm will receive Gou-Teng-San (GTS) orally at a dose of 5 g twice daily (total daily dose: 10 g), once in the morning and once in the evening, for 4 consecutive weeks.
DRUGPlacebo
Participants in this arm will receive placebo (starch) orally at a dose of 5 g twice daily (total daily dose: 10 g), once in the morning and once in the evening, for 4 consecutive weeks.
Sponsors
Tsai, Chueh-Yi, MD
Chung Shan Medical University
China Medical University, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 70 years. * History of episodic migraine for at least 12 months before screening, meeting the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria, or clinically diagnosed migraine with no more appropriate ICHD-3 diagnosis. * During the 28-day screening period, participants must meet criteria for episodic migraine, defined as headache occurring on \>=6 and \<=14 days, of which \>=4 days meet at least 1 of the following: (1) ICHD-3 criteria C and D for 1.1 migraine without aura; (2) ICHD-3 criteria B and C for 1.2 migraine with aura; (3) probable migraine (missing 1 migraine criterion); or (4) headache considered to be migraine based on a positive response to migraine-specific acute treatment (e.g., a triptan or an ergotamine derivative). * Not receiving preventive migraine medication for at least 5 half-lives before enrollment, or receiving no more than 1 preventive migraine medication at a stable dose and regimen for at least 2 months before informed consent, whether for migraine or another medical condition (e.g., propranolol for hypertension). * Body mass index (BMI) between 17.5 and 37.5 kg/m2, and body weight between 35 and 120 kg. * Adequate compliance with headache diary completion during screening, defined as completion on at least 24 of 28 days (\>=85%), with diary data considered acceptable by the investigator. * Able to comply with study restrictions and complete all protocol-required study procedures. * Able to understand and sign the informed consent form. * No major cardiovascular, hepatic, or renal disease.
Exclusion criteria
* Known allergy or hypersensitivity to Gou-Teng-San or any of its ingredients. * Receipt of botulinum toxin type A injections in the head, face, or neck for any reason within 4 months before screening. * Use of opioid-containing or barbiturate-containing medications on more than 4 days per month. * Lack of efficacy after at least 3 months of treatment at accepted migraine treatment doses in 2 or more of the following preventive medication classes: (1) topiramate or valproic acid; (2) flunarizine; (3) amitriptyline, venlafaxine, or duloxetine; (4) atenolol or propranolol. * Use of migraine treatment interventions within 2 months before screening, such as nerve block or transcranial magnetic stimulation. * Clinically significant hematologic, cardiac, renal, endocrine, pulmonary, gastrointestinal, urinary, neurologic, hepatic, ophthalmologic, psychiatric, or other disease that, in the investigator's judgment, would interfere with study participation or study procedures. * Participation in another clinical trial of a drug or medical device within 2 months before screening, or within 5 half-lives of the investigational product used in that trial, whichever is longer. * Use of other Chinese herbal medicines within 4 weeks before screening. * Previous exposure to monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway or CGRP receptor antagonists. * History of alcohol or drug abuse within the past 2 years. * Women who are breastfeeding, have a positive pregnancy test at screening, or are unwilling to use contraception during the study if of childbearing potential. * Any other condition or circumstance that, in the investigator's judgment, would make the participant unsuitable for the study or unlikely to complete the study successfully.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Mean Monthly Migraine Days at 4 Weeks | From baseline to Week 4 |
Countries
Taiwan
Contacts
CONTACTChueh-Yi Tsai, MD, MS
Outcome results
None listed