[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616506":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":37,"locations":11,"responsibleParty":43,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":11},{"fullName":5,"class":6},"Hubei Hospital of Traditional Chinese Medicine","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment of Compound Ciwujia Granules","EXPERIMENTAL",null,[13],"Drug: Compound Ciwujia Granules group",{"label":15,"type":16,"description":11,"interventionNames":17},"Treatment of estazolam","ACTIVE_COMPARATOR",[18],"Drug: Estazolam",{"label":20,"type":6,"description":11,"interventionNames":21},"Combined treatment of Compound Ciwujia Granules and estazolam",[22],"Drug: Compound Ciwujia Granules and estazolam",[24,29,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","Compound Ciwujia Granules group","Compound Ciwujia Granules for 4 consecutive weeks combined with placebo of estazolam for 4 consecutive weeks",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Estazolam","estazolam for 2 consecutive weeks + placebo of estazolam for 2 consecutive weeks combined with placebo of Compound Ciwujia Granules for 4 consecutive weeks",[15],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Compound Ciwujia Granules and estazolam","Compound Ciwujia Granules for 4 consecutive weeks combined with estazolam for 2 consecutive weeks+ placebo of estazolam for 2 consecutive weeks",[20],[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Gang Chen, PhD","CONTACT","+86-17771811588","250149875@qq.com",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Hui Zhu","Resident Physician","100616506","phase-4-compound-ciwujia-granules-in-the-treatment-of-insomnia-100616506",false,"NCT07306494","Compound Ciwujia Granules in the Treatment of Insomnia","Compound Ciwujia Granules in the Treatment of Insomnia: a Multi-center, Double-blind, Double-dummy, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Eligible participants were adults aged 40-75 years who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition \\[DSM5\\]);\n2. self-reported history of disturbed sleep (i.e, all the following: ≥30 min to fall asleep, ≥30 min awake during sleep time, and self-reported total sleep time of ≤6·5 h) on at least three nights per week for at least 3 months before screening;(3) diagnosis of \"deficiency of the heart and the spleen pattern\" or \"Qi deficiency of the heart and gallbladder pattern\" according to the guidelines for Integrated Traditional Chinese and Western Medicine Treatment of Insomnia Disorders 2023;\n\n(4) baseline Pittsburgh Sleep Quality Index (PSQI) score ≥ 8.\n\nExclusion Criteria:\n\n1. self-reported allergy symptoms to any of the ingredients;\n2. serious physical sickness;\n3. a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy;\n4. baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;\n5. pregnant women;\n6. history of drugs or alcohol abuse\u002Fdependence;\n7. presence of other sleep disorders including sleep apnoea, restless legs syndrome;\n8. night, morning or rotating shift work;\n9. participation in concurrent clinical trials.","ALL","40 Years","75 Years",{"count":58,"type":59},1200,"ESTIMATED","INTERVENTIONAL",[62],"PHASE4","The goal of this multicenter, double-blind, double-dummy, randomized controlled trial was to examine the efficacy and safety of Compound Ciwujia Granules in the treatment of chronic insomnia. A total of 1200 participants with chronic insomnia were randomly assigned to receive one of the three treatment for 4 consecutive weeks: Compound Ciwujia Granules + placebo of estazolam, estazolam + placebo of estazolam + placebo of Compound Ciwujia Granules, or Compound Ciwujia Granules + estazolam + placebo of estazolam. Outcomes were assessed at 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The main questions it aims to answer are:\n\n1. Are there any significant differences between groups regarding changes in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedative and hypnotics use, improvement in sleep maintenance, Hamilton Depression Scale (HAMD-17) score, Hamilton Anxiety Scale (HAMA-14) score, Flinders Fatigue Scale (FFS) score, and constitution classification\u002Finsomnia pattern score of traditional Chinese medicine after 4 weeks' treatment, and follow-up at 8 weeks and 12 weeks.\n2. Is the Compound Ciwujia Granules a safe method for chronic insomnia treatment in adults?",[65],"Insomnia Disorder",[67,68,69,70],"Compound Ciwujia Granules","multicenter","randomized controlled trial","insomnia","NOT_YET_RECRUITING","2025-12-14",{"date":74,"type":75},"2025-12-29","ACTUAL",{"date":77,"type":59},"2026-01",{"date":79,"type":59},"2028-06",{"name":45,"class":6}]