Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine (GTSEM)

May 18, 2026 updated by: Tsai, Chueh-Yi, MD

"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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • South
      • Taichung, South, Taiwan, 402306
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
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.
Other Names:
  • Placebo and stabdard care
Experimental: Gou-Teng-San
Drug: Gou-Teng-San
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.
Other Names:
  • Gou-Teng-San and standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Mean Monthly Migraine Days at 4 Weeks
Time Frame: From baseline to Week 4
From baseline to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tsai, Chueh-Yi, MD

Collaborators

Chung Shan Medical University
China Medical University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS1-25048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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