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| Name | Class |
|---|---|
| Chung Shan Medical University | OTHER |
| China Medical University, Taiwan | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gou-Teng-San | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gou-Teng-San | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Mean Monthly Migraine Days at 4 Weeks | From baseline to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chueh-Yi Tsai, MD, MS | Contact | 886-4-2473-9595 | 801641 | neurojoule@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Recruiting | Taichung | South | 402306 | Taiwan |
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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Placebo | Drug | 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. |
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