[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468725":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":25,"studyPopulation":17,"armGroups":26,"interventions":38,"overallOfficials":48,"centralContacts":52,"locations":63,"responsibleParty":116,"collaborators":17,"id":120,"slug":17,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":17,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":17,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":141,"whyStopped":17,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Peking University Shenzhen Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Cure rate of refractory trichomoniasis","Evaluate the efficacy of oral tinidazole tablets in the treatment of refractory trichomoniasis.Diagnosis of vaginal trichomoniasis is performed by microscopy of vaginal secretions. Cure or failure was based on positive or negative T. vaginalis on vaginal secretions by microscopy examination.","24 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"Safety of tinidazole tablets","Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Test of blood routine,liver function, kidney function ,and urine routine will be done before treatment.The same test will be were reviewed within 1 week after treatment.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","SINGLE_GROUP","For patients who failed to conventional treatment (recommended by the guidelines including tinidazole, 2g once daily for 5-7 days), the following regimens were selected: Tinidazole , 2g twice daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.\n\nTinidazole , 1g three times daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.","TREATMENT",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE","Refractory trichomonas vaginitis has become a clinical problem, which has a direct impact on the health and life of patients. Refractory trichomonas vaginitis is mainly caused by drug resistance of trichomonas. Drug resistant trichomonas has appeared China. Increasing the dosage of anti trichomonal drugs is the main treatment method at present. The aim of this study was to evaluate the efficacy and safety of two oral tinidazole regimens for refractory trichomonas vaginitis.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Tinidazole 56","EXPERIMENTAL","Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.",[32],"Drug: Tinidazole 42",{"label":34,"type":29,"description":35,"interventionNames":36},"Tinidazole 42","Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.",[37],"Drug: Tinidazole 56",[39,44],{"type":40,"name":28,"description":30,"armGroupLabels":41,"otherNames":42},"DRUG",[34],[43],"Tinidazole M56",{"type":40,"name":34,"description":35,"armGroupLabels":45,"otherNames":46},[28],[47],"Tinidazole M42",[49],{"name":50,"affiliation":5,"role":51},"Shangrong Fan Fan, M.D.","PRINCIPAL_INVESTIGATOR",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Yiheng Liang, M.D.","CONTACT","86-755-83923333","5518","13510331823@163.com",{"name":60,"role":55,"phone":56,"phoneExt":61,"email":62},"Ping Liu, M.D.","5505","253783006@qq.com",[64,83,96,106],{"facility":5,"status":17,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Shenzhen","Guangdong","518000","China","CN",{"type":71,"coordinates":72},"Point",[73,74],114.0683,22.54554,{"lat":74,"lon":73},[77,79,81],{"name":78,"role":55,"phone":56,"phoneExt":57,"email":58},"Yiheng liang, M.D.",{"name":80,"role":55,"phone":56,"phoneExt":61,"email":62},"Ping liu, M.D.",{"name":82,"role":51,"phone":17,"phoneExt":17,"email":17},"Shangrong Fan, MD",{"facility":84,"status":17,"city":85,"state":17,"zip":17,"country":68,"countryCode":69,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Beijing Obstetrics and Gynecology Hospital,Capital Medical University","Beijing",{"type":71,"coordinates":87},[88,89],116.39723,39.9075,{"lat":89,"lon":88},[92,94],{"name":93,"role":55,"phone":17,"phoneExt":17,"email":17},"Zhaohui Liu, M.D.",{"name":95,"role":51,"phone":17,"phoneExt":17,"email":17},"Zhaohui Liu",{"facility":97,"status":17,"city":85,"state":17,"zip":17,"country":68,"countryCode":69,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University",{"type":71,"coordinates":99},[88,89],{"lat":89,"lon":88},[102,104],{"name":103,"role":55,"phone":17,"phoneExt":17,"email":17},"Qinping Liao, M.D.",{"name":105,"role":51,"phone":17,"phoneExt":17,"email":17},"Qinping Liao",{"facility":107,"status":17,"city":85,"state":17,"zip":17,"country":68,"countryCode":69,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"Peking University First Hospital",{"type":71,"coordinates":109},[88,89],{"lat":89,"lon":88},[112,114],{"name":113,"role":55,"phone":17,"phoneExt":17,"email":17},"Dai Zhang, M.D.",{"name":115,"role":51,"phone":17,"phoneExt":17,"email":17},"Dai Zhang",{"type":117,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"SPONSOR_INVESTIGATOR","Shangrong Fan","Profesor","100468725",false,"NCT05383521","Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis","Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis","Inclusion Criteria:\n\n* Women be at least 18 years of age\n* Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)\n\nExclusion Criteria:\n\n* Allergy to metronidazole or tinidazol\n* Pregnant or nursing\n* HIV or other chronic disease","FEMALE","18 Years","55 Years",{"count":130,"type":131},20,"ESTIMATED","INTERVENTIONAL",[134],"NA","We compare two oral tinidazole regimens for refractory trichomonas vaginitis.",[137],"Trichomonas Vaginitis",[139,140],"Refractory Trichomonas Vaginitis","Tinidazole","NOT_YET_RECRUITING","2024-06-08",{"date":144,"type":145},"2024-06-11","ACTUAL",{"date":147,"type":131},"2025-12-01",{"date":149,"type":131},"2025-12-30",{"name":118,"class":6},4]