Episodic MigrainePhase 3GTSEMNCT07496034
Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine
A Phase 3 study testing Gou-Teng-San in people with Episodic Migraine, run by Tsai, Chueh-Yi, MD at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Episodic Migraine
- What is being tested?
- Gou-Teng-San
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung, South, 402306
Chueh-Yi Tsai, MD, MS, 886-4-2473-9595 ext. 801641, neurojoule@gmail.com
About this study
Official title: "Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial" (GTSEM Trial)
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.
- Conditions
- Episodic Migraine
- Being tested
- Gou-Teng-San, Placebo
- Keywords
- Episodic migraine, Gou-Teng-San, Gou Teng San, Choto-san
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gou-Teng-SanDrug
Also called Gou-Teng-San and standard care
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.
PlaceboDrug
Also called Placebo and stabdard care
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.
| Study group | Role | What they receive |
|---|---|---|
| Gou-Teng-San | Experimental | Not described Receives: Drug: Gou-Teng-San |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Mean Monthly Migraine Days at 4 Weeks
Measured: From baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tsai, Chueh-Yi, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Chung Shan Medical University, China Medical University, Taiwan
- Responsible party
- Sponsor-investigator, Tsai, Chueh-Yi, MD, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496034
- Sponsor's protocol ID
- CS1-25048
- Acronym
- GTSEM
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data (IPD) with other researchers because data-sharing procedures and governance mechanisms have not yet been established. Any future data sharing will be considered only after appropriate de-identification procedures, institutional review board approval, institutional policies, and applicable regulations are in place.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial" (GTSEM Trial)
- ClinicalTrials.gov ID
- NCT07496034
- Acronym / sponsor ID
- GTSEM / CS1-25048
- Conditions
- Episodic Migraine
- Keywords
- Episodic migraine, Gou-Teng-San, Gou Teng San, Choto-san
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tsai, Chueh-Yi, MDUniversity, hospital or other
- Collaborators
- Chung Shan Medical University, China Medical University, Taiwan
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gou-Teng-San | Experimental | Drug: Gou-Teng-San |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gou-Teng-SanAlso: Gou-Teng-San and standard careParticipants 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. | Drug | Gou-Teng-San |
| PlaceboAlso: Placebo and stabdard careParticipants 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. | Drug | Placebo |
Primary outcome
Change from Baseline in Mean Monthly Migraine Days at 4 Weeks
Time frame: From baseline to Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data (IPD) with other researchers because data-sharing procedures and governance mechanisms have not yet been established. Any future data sharing will be considered only after appropriate de-identification procedures, institutional review board approval, institutional policies, and applicable regulations are in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gou-Teng-San in people with Episodic Migraine, run by Tsai, Chueh-Yi, MD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chueh-Yi Tsai, MD, MS (886-4-2473-9595 ext. 801641, neurojoule@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Mean Monthly Migraine Days at 4 Weeks (time frame: From baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.