Ancient herb Gou-Teng-San put to the test for migraine sufferers
NCT ID NCT07496034
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether Gou-Teng-San (GTS), a traditional herbal medicine, can help adults with episodic migraine. About 40 participants will be randomly assigned to receive GTS or a placebo. Researchers will measure if GTS reduces the number of migraine days per month and eases migraine-related symptoms over 4 weeks. The goal is to find a safe, natural option for migraine relief.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chung Shan Medical University Hospital
RECRUITINGTaichung, South, 402306, Taiwan
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