[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498580":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":52,"studyPopulation":40,"armGroups":53,"interventions":66,"overallOfficials":76,"centralContacts":81,"locations":87,"responsibleParty":104,"collaborators":40,"id":106,"slug":40,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":40,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":40,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":40,"overallStatus":89,"whyStopped":40,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},{"fullName":5,"class":6},"Chengdu Kanghong Pharmaceutical Group Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in the HAM-A Total Score at Week 12","The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.","Change from Baseline to Week 12",[14,17,20,22,25,28,31,34,37],{"measure":15,"description":11,"timeFrame":16},"Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8","Change from Baseline to Week 2, 4, and 8",{"measure":18,"description":11,"timeFrame":19},"The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;","Change from Baseline to Week 2, 4, 8 and 12",{"measure":21,"description":11,"timeFrame":19},"The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12",{"measure":23,"description":24,"timeFrame":19},"Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12","HAM-A Mental Anxiety Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28.",{"measure":26,"description":27,"timeFrame":19},"Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12","The HAM-A Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28.",{"measure":29,"description":30,"timeFrame":19},"Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12","The scale evaluates the quality of life in four areas: physiology, psychology, social relations and environment.",{"measure":32,"description":33,"timeFrame":19},"Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12","The CGI-S is measures the clinician's impression of a subject's current anxiety severity considering their total clinical experience with the patient population. This measure uses a 0-7 scale, with higher scores indicating greater anxiety severity.",{"measure":35,"description":36,"timeFrame":19},"Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12","CGI-I measured the clinician's perception of the participant's improvement at the time of assessment compared with the baseline. Scores could have ranged from 1 (very much improved) to 7 (very much worse).",{"measure":38,"description":39,"timeFrame":19},"Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12","TCM syndrome scale was used to evaluate the changes of TCM symptoms and signs before and after treatment.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":47},"QUADRUPLE",[48,49,50,51],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).\n\nIn stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.\n\nIn stage 2, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"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.",[59],"Drug: Shugan Jieyu Capsules",{"label":61,"type":62,"description":63,"interventionNames":64},"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.",[65],"Drug: Shugan Jieyu Capsules Placebo",[67,72],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":40},"DRUG","Shugan Jieyu Capsules","Oral, 4 Capsules, BID",[55],{"type":68,"name":73,"description":74,"armGroupLabels":75,"otherNames":40},"Shugan Jieyu Capsules Placebo","Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID\n\nDrug: Placebo, Oral, 1 capsule, BID",[61],[77],{"name":78,"affiliation":79,"role":80},"Gang Wang, MD","Beijing Anding Hospital Affiliated to Capital Medical University","PRINCIPAL_INVESTIGATOR",[82],{"name":83,"role":84,"phone":85,"phoneExt":40,"email":86},"Ling Song","CONTACT","028-81258178","022516@cnkh.com",[88],{"facility":79,"status":89,"city":90,"state":40,"zip":40,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"RECRUITING","Beijing","China","CN",{"type":94,"coordinates":95},"Point",[96,97],116.39723,39.9075,{"lat":97,"lon":96},[100],{"name":101,"role":84,"phone":102,"phoneExt":40,"email":103},"Gang Wang","+8613911695727","adgangwang@163.com",{"type":105,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","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":116,"type":117},495,"ESTIMATED","INTERVENTIONAL",[120],"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.",[123],"Generalized Anxiety Disorder","2024-12-17",{"date":126,"type":127},"2024-12-18","ACTUAL",{"date":129,"type":127},"2023-04-17",{"date":131,"type":117},"2025-06-01",{"name":133,"class":6},"Sichuan Jishengtang Pharmaceutical Co., Ltd.",1]