[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631081":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":31,"locations":38,"responsibleParty":55,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"China Medical University, Taiwan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gou-Teng-San","EXPERIMENTAL",null,[13],"Drug: Gou-Teng-San",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[9],[25],"Gou-Teng-San and standard care",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"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.",[15],[30],"Placebo and stabdard care",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Chueh-Yi Tsai, MD, MS","CONTACT","886-4-2473-9595","801641","neurojoule@gmail.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Chung Shan Medical University Hospital","RECRUITING","Taichung","South","402306","Taiwan","TW",{"type":48,"coordinates":49},"Point",[50,51],120.6839,24.1469,{"lat":51,"lon":50},[54],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","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",[60,62],{"name":61,"class":6},"Chung Shan Medical University",{"name":5,"class":6},"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":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82],"Episodic Migraine",[84,9,85,86],"Episodic migraine","Gou Teng San","Choto-san","2026-05-18",{"date":89,"type":90},"2026-05-20","ACTUAL",{"date":92,"type":90},"2025-07-01",{"date":94,"type":76},"2026-12-31",{"name":57,"class":6},1]