[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557177":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},{"fullName":5,"class":6},"Chengdu Kanghong Pharmaceutical Group Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Wujia Yizhi Granules","EXPERIMENTAL","Participants received Wujia Yizhi Granules 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months.",[13],"Drug: Wujia Yizhi granules",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants received Wujia Yizhi granules simulator 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Wujia Yizhi granules","Drug: Wujia Yizhi granuless",[9],null,{"type":22,"name":15,"description":15,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"affiliation":32,"role":33},"Xiaochun Chen, Medical Doctor","Fujian Medical University Affiliated Union Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Lin song","CONTACT","028-81258178","022516@cnkh.com",[41],{"facility":32,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"RECRUITING","Fuzhou","Fujian","350000","China","CN",{"type":49,"coordinates":50},"Point",[51,52],119.30611,26.06139,{"lat":52,"lon":51},{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100557177","phase-3-phase-3-clinical-trial-of-wujia-yizhi-granules-in-the-treatment-of-mild-to-moderate-alzheimers-dementia-syndrome-of-deficiency-of-spleen-and-kidney-100557177",false,"NCT06534723","Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney)","A 12-month Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney).","Inclusion Criteria:\n\n1. Male or female, age range : 50 - 80 years old.\n2. Informed consent signed and dated by patient or legal representative.\n3. The participants are mild-to-moderate AD patients who meet the diagnostic criteria for AD proposed by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2018 and have a disease course of more than 6 months. If participants lack previous pathological evidence or biomarkers of Alzheimer's dementia, they must have evidence of β-amyloid deposition biomarkers during screening (PET with abnormal amyloid deposition or low cerebrospinal fluid Aβ 42 and Aβ 42\u002FAβ 40 ratio).\n4. MMSE score 11 to 26;CDR-GS score 1 to 2 。\n\nExclusion Criteria:\n\n1. Participants with non AD induced memory and cognitive impairment, such as diagnosis of other types of dementia, including but not limited to mixed dementia (AD VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), Lewy body dementia (DLB), Huntington's disease related dementia, frontotemporal lobe dementia (FTD), etc; Endocrine system disorders (such as thyroid diseases, parathyroid diseases) and dementia caused by folate, vitamin B12 deficiency, or any other reason; Existence of consciousness disorders, etc.\n2. Participants have a history of epileptic seizures.\n3. Participants are psychiatric patients, including but not limited to schizophrenia, affective schizophrenic disorder, bipolar disorder, or delirium.\n4. HAMD-17 score ≥ 17 points.\n5. HAMA score ≥ 14 points.\n6. Participants were taking antidepressants, anxieties, and antipsychotic drugs during screening.\n7. HIS score ≥ 4 points..","ALL","50 Years","80 Years",{"count":67,"type":68},570,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","This study is a randomized, double-blind, placebo-controlled phase 3 design aimed at further verifying the safety and efficacy of Wujia Yizhi granules for mild-to-moderate Alzheimer's dementia",[74],"Alzheimer's Dementia","2025-12-25",{"date":77,"type":78},"2025-12-29","ACTUAL",{"date":80,"type":78},"2024-08-20",{"date":82,"type":68},"2026-12-01",{"name":84,"class":6},"Sichuan Jishengtang Pharmaceutical Co., Ltd.",1]