[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614995":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":29,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":10,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":10,"studyType":47,"phases":10,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Hubei Hospital of Traditional Chinese Medicine","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"insomnia patients",null,[12],"Drug: Ciwujia Capsules\u002FCompound Ciwujia Granules",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","Ciwujia Capsules\u002FCompound Ciwujia Granules","Ciwujia Capsule may promote sleep because it has the function of strengthening the spleen, tonifying the kidney, and calming the mind.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Gang Chen, PhD","CONTACT","+86-17771811588","250149875@qq.com",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Hui Zhu","Clinical Professor",[30,32],{"name":31,"class":6},"Huazhong University of Science and Technology",{"name":33,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","100614995","ciwujia-capsulescompound-ciwujia-granules-in-the-treatment-of-insomnia-100614995",false,"NCT07286838","Ciwujia Capsules\u002FCompound Ciwujia Granules in the Treatment of Insomnia","Effects of Ciwujia Capsules\u002FCompound Ciwujia Granules in the Treatment of Insomnia: a Multicenter, Prospective Real-world Study","Inclusion Criteria:\n\n* adults aged 18-75 years old who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition \\[DSM5\\]), or self-reported history of disturbed sleep.\n\nExclusion Criteria:\n\n* (1) self-reported allergy symptoms to any of the ingredients; (2) serious physical sickness; (3) a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy; (4) baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;(5) pregnant women; (6) history of drugs or alcohol abuse\u002Fdependence; (7) presence of other sleep disorders including sleep apnoea, restless legs syndrome; (8) participation in concurrent clinical trials.The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) score.","ALL","18 Years","75 Years",{"count":45,"type":46},40000,"ESTIMATED","OBSERVATIONAL","The goal of this real-world study is to investigate the efficacy and safety of \"Ciwujia Capsules\u002FCompound Ciwujia Granules\" in the treatment of insomnia in the clinical real-world. A total of 40000 patients with insomnia are assigned to 8 weeks of Ciwujia Capsules\u002FCompound Ciwujia Granules treatment. The main question it aims to answer is:\n\n1. Is there any significant reduction in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedatives or hypnotics use, and improvement in sleep maintenance after 8 weeks treatment of Ciwujia Capsules\u002FCompound Ciwujia Granules?\n2. Is Ciwujia Capsules\u002FCompound Ciwujia Granules\" a safe method for treating insomnia in adults?",[50],"Insomnia Disorders",[16,52,53],"Insomnia","real-world study","NOT_YET_RECRUITING","2025-12-13",{"date":57,"type":58},"2025-12-16","ACTUAL",{"date":60,"type":46},"2026-01-01",{"date":62,"type":46},"2028-06-01",{"name":27,"class":6}]