NCT07496034招募中3 期
"Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial" (GTSEM Trial)
Tsai, Chueh-Yi, MD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Tsai, Chueh-Yi, MD
Attending Physician, Department of Neurology, Chung Shan Medical University Hospital; Ph.D. Student, Graduate Institute of Integrated Medicine, China Medical University
China Medical University, Taiwan
研究点 (1)
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