[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539786":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"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,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fengzeng Jian","RECRUITING","Beijing","Beijing Municipality","100053","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55,57,59],{"name":56,"role":33,"phone":26,"phoneExt":26,"email":38},"Yuan Chenghua",{"name":58,"role":33,"phone":26,"phoneExt":26,"email":35},"Jian Fengzeng",{"name":60,"role":61,"phone":26,"phoneExt":26,"email":26},"jian guan, dr","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100539786","phase-2-the-therapeutic-effect-of-betaine-in-syringomyelia-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":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82],"Syringomyelia","2024-03-11",{"date":85,"type":86},"2024-03-13","ACTUAL",{"date":88,"type":76},"2024-03",{"date":90,"type":76},"2028-03",{"name":5,"class":6},1]