Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine
ConditionEpisodic Migraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTsai, Chueh-Yi, MD
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Gou-Teng-San
DrugParticipants 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.
Placebo
DrugParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Gou-Teng-SanExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Mean Monthly Migraine Days at 4 Weeks
Time frame
From baseline to Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tsai, Chueh-Yi, MD
Lead sponsor
China Medical University, Taiwan
Sponsor institution
Chung Shan Medical University
Collaborator
China Medical University, Taiwan
Collaborator
Source ClinicalTrials.gov