Actively Recruiting
Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial (GTSEM Trial)
Led by Tsai, Chueh-Yi, MD · Updated on 2026-05-20
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tsai, Chueh-Yi, MD
Lead Sponsor
C
Chung Shan Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether Gou-Teng-San (GTS), a traditional herbal medicine, is effective and safe for adults with episodic migraine. This Phase 3 double-blind randomized controlled trial aims to see if GTS can reduce the number of migraine days, improve migraine symptoms, and lessen the impact of migraines on daily life. Safety and tolerability will be monitored throughout the study period. Participants will be randomly assigned to receive either Gou-Teng-San or a placebo (starch), both given orally at a dose of 5 grams twice daily, once in the morning and once in the evening, for 4 consecutive weeks. The study includes a screening period followed by the 4-week treatment phase. During the study, participants will track their migraines using a headache diary and undergo assessments to measure changes in migraine frequency from baseline to the fourth week. Researchers will also monitor safety, tolerability, and participant compliance. The primary outcome is the change in the average number of migraine days per month after 4 weeks of treatment.
CONDITIONS
Brief Title
Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- History of episodic migraine for at least 12 months meeting ICHD-3 criteria or clinically diagnosed migraine
- Episodic migraine during 28-day screening with 6 to 14 headache days, including at least 4 migraine days
- Not receiving preventive migraine medication for at least 5 half-lives before enrollment, or stable on no more than one preventive medication for at least 2 months
- Body mass index between 17.5 and 37.5 kg/m2 and weight between 35 and 120 kg
- Completed at least 85% of headache diary entries during screening
- Able to comply with study procedures and restrictions
- Able to understand and sign informed consent
- No major cardiovascular, liver, or kidney disease
You will not qualify if you...
- Allergy or hypersensitivity to Gou-Teng-San or its ingredients
- Botulinum toxin type A injections in head, face, or neck within 4 months
- Use of opioid- or barbiturate-containing medications more than 4 days per month
- Lack of efficacy after 3 months of treatment in 2 or more preventive medication classes
- Use of migraine treatments like nerve block or transcranial magnetic stimulation within 2 months
- Significant medical conditions that interfere with study participation
- Participation in another drug or device clinical trial within 2 months or within 5 half-lives of investigational product
- Use of other Chinese herbal medicines within 4 weeks
- Previous exposure to monoclonal antibodies targeting CGRP pathway or receptor antagonists
- History of alcohol or drug abuse in past 2 years
- Breastfeeding, positive pregnancy test, or unwillingness to use contraception if of childbearing potential
- Any condition deemed unsuitable by investigator for study participation or completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive Gou-Teng-San or placebo orally twice daily for 4 consecutive weeks.
Weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
Chung Shan Medical University Hospital
Taichung, South, Taiwan, 402306
Actively Recruiting
Research Team
C
Chueh-Yi Tsai, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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