Actively Recruiting
Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial
Led by Tsai, Chueh-Yi, MD · Updated on 2026-03-27
40
Participants Needed
1
Research Sites
78 weeks
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
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
Official Title
Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial
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
- During 28-day screening, headache on 6 to 14 days with at least 4 days meeting migraine criteria
- Not receiving preventive migraine medication for at least 5 half-lives before enrollment, or on stable dose of no more than 1 preventive medication for at least 2 months
- Body mass index (BMI) between 17.5 and 37.5 kg/m2 and body weight between 35 and 120 kg
- Compliance with headache diary completion on at least 24 of 28 days during screening
- Able to comply with study restrictions and complete all study procedures
- 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 before screening
- Use of opioid or barbiturate medications more than 4 days per month
- Lack of efficacy after at least 3 months of treatment with 2 or more preventive medication classes
- Use of migraine treatment interventions like nerve block or transcranial magnetic stimulation within 2 months before screening
- Significant hematologic, cardiac, renal, endocrine, pulmonary, gastrointestinal, urinary, neurologic, hepatic, ophthalmologic, psychiatric, or other disease that may affect participation
- Participation in another drug or device clinical trial within 2 months before screening or within 5 half-lives of investigational product
- Use of other Chinese herbal medicines within 4 weeks before screening
- Previous exposure to monoclonal antibodies targeting CGRP pathway or receptor antagonists
- History of alcohol or drug abuse within past 2 years
- Women who are breastfeeding, pregnant, or unwilling to use contraception if of childbearing potential
- Any other condition making the participant unsuitable or unlikely to complete the study successfully
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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