[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539786":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":61,"collaborators":26,"id":63,"slug":26,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"betaine","EXPERIMENTAL","oral betaine",[13],"Drug: Betaine",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","rice-flour as a placebo",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Betaine","50mg\u002Fkg for 12 weeks",[9],null,{"type":22,"name":28,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"jian fengzeng","CONTACT","+861083198899","jianfengzeng@xwh.ccmu.edu.cn",{"name":37,"role":33,"phone":34,"phoneExt":26,"email":38},"chenghua yuan","yuanchenghua@ccmu.edu.cn",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Fengzeng Jian","RECRUITING","Beijing","Beijing Municipality","100053","China",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54,56,58],{"name":55,"role":33,"phone":26,"phoneExt":26,"email":38},"Yuan Chenghua",{"name":57,"role":33,"phone":26,"phoneExt":26,"email":35},"Jian Fengzeng",{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"jian guan, dr","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100539786",false,"NCT06308367","The Therapeutic Effect of Betaine in Syringomyelia","The Effect of Betaine in Refractory Syringomyelia（RS）","Inclusion Criteria:\n\n* Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects,\n* non-effective response to duraplasty and shunting treatment in 12 months prior to study entry.\n* Estimated life expectancy must be greater than 12 months.\n* Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document.\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* Participants have a cardiometabolic disease for which they take prescribed medications\n* Evidence of tumor metastasis, recurrence, or invasion;\n* History of psychiatric diseases ;\n* History of seizures;\n* History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infaction, unstable angina, within 6 months;\n* New York Heart Association Grade II or greater congestive heart failure;\n* Serious and inadequately controlled cardiac arrhythmia;\n* Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, -history of aortic dissection;\n* Severe infection;\n* History of allergy to relevant drugs;\n* Pregnancy, lactation, or fertility program in the following 12 months;\n* History or current diagnosis of peripheral nerve disease;\n* Abnormal in liver and renal function;\n* Active tuberculosis;\n* Transplanted organs;\n* Human immunodeficiency virus;\n* Participation in other experimental studies.","ALL","18 Years","80 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","Purpose: This clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine in refractory syringomyelia.\n\nPrimary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before betaine usage.",[80],"Syringomyelia","2024-03-11",{"date":83,"type":84},"2024-03-13","ACTUAL",{"date":86,"type":74},"2024-03",{"date":88,"type":74},"2028-03",{"name":5,"class":6},1]