[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591476":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":60,"collaborators":44,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":44,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":44,"enrollmentInfo":70,"targetDuration":44,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":88,"whyStopped":44,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Chang Gung Memorial Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Participants in Group A will receive Guilu Erxian Jiao (GLJ) plus usual care for 4 weeks, followed by a 4-week washout period, then 4 weeks of usual care alone.",[13],"Drug: Guilu Erxian Jiao",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","ACTIVE_COMPARATOR","Participants in Group B will receive usual care alone for 4 weeks, followed by a 4-week washout period, then 4 weeks of Guilu Erxian Jiao (GLJ) plus usual care.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Guilu Erxian Jiao","A traditional Chinese herbal formula composed of Testudinis Carapax, Cervi Cornu, Lycii Fructus, and Ginseng Radix, manufactured by Sun Ten Pharmaceutical Co., Ltd. (License No. 016966). Administered orally at 4 grams per day before meals for 4 weeks.",[9,15],[26],"Jipin Guilu Baishen San",[28],{"name":29,"affiliation":30,"role":31},"Huan-Hsuan Hsu, M.D.","Department of Chinese Medicine, Keelung Chang Gung Memorial Hospital","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","+886-2-24313131","2677","10356017a@cgmh.org.tw",{"name":39,"role":34,"phone":35,"phoneExt":36,"email":40},"Chun-Jung Lin, M.D.","s81101911@cgmh.org.tw",[42],{"facility":43,"status":44,"city":45,"state":44,"zip":44,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Keelung Chang Gung Memorial Hospital",null,"Keelung","Taiwan","TW",{"type":49,"coordinates":50},"Point",[51,52],121.74094,25.13089,{"lat":52,"lon":51},[55,56,57,58],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":39,"role":34,"phone":35,"phoneExt":36,"email":40},{"name":29,"role":31,"phone":44,"phoneExt":44,"email":44},{"name":39,"role":59,"phone":44,"phoneExt":44,"email":44},"SUB_INVESTIGATOR",{"type":61,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100591476","phase-2-the-efficacy-and-safety-of-guilu-erxian-jiao-in-the-treatment-of-intradialytic-hypotension-100591476",false,"NCT06980922","The Efficacy and Safety of Guilu Erxian Jiao in the Treatment of Intradialytic Hypotension","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing maintenance hemodialysis three times per week, 4 hours per session\n* History of intradialytic hypotension (IDH)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Severe comorbid illness, such as cancer, stroke, or liver cirrhosis\n* Inability to comply with study medication regimen\n* Regular use of antihypertensive medication","ALL","18 Years",{"count":71,"type":72},34,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","The goal of this clinical trial is to learn if Guilu Erxian Jiao, a traditional Chinese herbal medicine, can help manage intradialytic hypotension (IDH), a drop in blood pressure that occurs during hemodialysis in adults. The main questions it aims to answer are:\n\n1. Does Guilu Erxian Jiao reduce the frequency and severity of low blood pressure during dialysis?\n2. Is Guilu Erxian Jiao safe to use in patients receiving hemodialysis?\n\nResearchers will compare standard care plus Guilu ErXian Jiao to standard care alone to see if Guilu Erxian Jiao improves blood pressure stability during dialysis.\n\nParticipants will:\n\n1. Take Guilu Erxian Jiao once daily in addition to standard care, or receive standard care alone, for 4 weeks, then switch treatments after a 4-week washout period (crossover design).\n2. Undergo follow-up assessments at weeks 2 and 4 after each treatment phase.\n3. Have their blood pressure monitored before, during (hourly), and after each dialysis session.\n4. Report dialysis-related symptoms such as dizziness and fatigue.\n5. Receive routine laboratory tests and safety monitoring throughout the study.",[78,79,80],"Intradialytic Hypotension","End-Stage Renal Disease","Hemodialysis",[78,80,82,83,22,79,84,85,86,87],"Traditional Chinese Medicine","Herbal Medicine","Randomized Controlled Trial","Kidney Disease","Dialysis Complications","Blood Pressure","NOT_YET_RECRUITING","2025-05-19",{"date":91,"type":92},"2025-05-20","ACTUAL",{"date":94,"type":72},"2025-06-01",{"date":96,"type":72},"2028-05-31",{"name":5,"class":6},1]