Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial
"Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial" (GTSEM Trial)
Tsai, Chueh-Yi, MD
40 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria12
- 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.
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07496034