[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498580":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},{"fullName":5,"class":6},"Chengdu Kanghong Pharmaceutical Group Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Shugan Jieyu Capsules","EXPERIMENTAL","Participants received Shugan Jieyu Capsules 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks.",[13],"Drug: Shugan Jieyu Capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental: Shugan Jieyu Capsules Placepo","PLACEBO_COMPARATOR","Participants received Shugan Jieyu Capsules Placebo 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks.",[19],"Drug: Shugan Jieyu Capsules Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Shugan Jieyu Capsules","Oral, 4 Capsules, BID",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Shugan Jieyu Capsules Placebo","Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID\n\nDrug: Placebo, Oral, 1 capsule, BID",[15],[32],{"name":33,"affiliation":34,"role":35},"Gang Wang, MD","Beijing Anding Hospital Affiliated to Capital Medical University","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Ling Song","CONTACT","028-81258178","022516@cnkh.com",[43],{"facility":34,"status":44,"city":45,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Beijing","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":39,"phone":57,"phoneExt":26,"email":58},"Gang Wang","+8613911695727","adgangwang@163.com",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100498580","phase-3-clinical-trial-of-shugan-jieyu-capsule-in-generalized-anxiety-disorder-100498580",false,"NCT05772104","Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder","A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder","Inclusion Criteria:\n\n1. Primary diagnosis of generalized anxiety disorder (GAD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by the MINI at Screening, The duration of illness must be ≥ 6 months；\n2. Age 18-65 years old；\n3. Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；\n4. Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline\n5. The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.\n\nExclusion Criteria:\n\n1. Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening；\n2. Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening\n3. Hamilton Depression Rating Scale (HAMD-17) Total Score of \\> 17 at Screening or Baseline，or Depressive Mood (item 1) score ≥2；\n4. Patients with Severe Insomnia.","ALL","18 Years","65 Years",{"count":72,"type":73},495,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder.",[79],"Generalized Anxiety Disorder","2024-12-17",{"date":82,"type":83},"2024-12-18","ACTUAL",{"date":85,"type":83},"2023-04-17",{"date":87,"type":73},"2025-06-01",{"name":89,"class":6},"Sichuan Jishengtang Pharmaceutical Co., Ltd.",1]