[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tsai, Chueh-Yi, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100631081","phase-3-efficacy-of-gou-teng-san-gts-in-patients-with-episodic-migraine-100631081",false,"NCT07496034","Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine","\"Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial\" (GTSEM Trial)","GTSEM","Inclusion Criteria:\n\n* Adults aged 18 to 70 years.\n* 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.\n* During the 28-day screening period, participants must meet criteria for episodic migraine, defined as headache occurring on \\>=6 and \\\u003C=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).\n* 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).\n* Body mass index (BMI) between 17.5 and 37.5 kg\u002Fm2, and body weight between 35 and 120 kg.\n* 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.\n* Able to comply with study restrictions and complete all protocol-required study procedures.\n* Able to understand and sign the informed consent form.\n* No major cardiovascular, hepatic, or renal disease.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to Gou-Teng-San or any of its ingredients.\n* Receipt of botulinum toxin type A injections in the head, face, or neck for any reason within 4 months before screening.\n* Use of opioid-containing or barbiturate-containing medications on more than 4 days per month.\n* 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.\n* Use of migraine treatment interventions within 2 months before screening, such as nerve block or transcranial magnetic stimulation.\n* 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.\n* 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.\n* Use of other Chinese herbal medicines within 4 weeks before screening.\n* Previous exposure to monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway or CGRP receptor antagonists.\n* History of alcohol or drug abuse within the past 2 years.\n* Women who are breastfeeding, have a positive pregnancy test at screening, or are unwilling to use contraception during the study if of childbearing potential.\n* 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.","ALL","18 Years","70 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28],"Episodic Migraine",[30,31,32,33],"Episodic migraine","Gou-Teng-San","Gou Teng San","Choto-san","RECRUITING","2026-05-18",{"date":37,"type":38},"2026-05-20","ACTUAL",{"date":40,"type":38},"2025-07-01",{"date":42,"type":22},"2026-12-31",{"name":44,"class":45},"Tsai, Chueh-Yi, MD","OTHER",""]