[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631734":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":39,"responsibleParty":57,"collaborators":60,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":25,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Shanghai 7th People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ningshen Danxiang Donkey-hide Gelatin Medicated Paste","EXPERIMENTAL","Formula Composition: Mori Fructus (Sang Shen \u002F Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi \u002F Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng \u002F Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi \u002F Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen \u002F Red sage root) 300 g Citri Medica Fructus (Xiang Yuan \u002F Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu \u002F Nutgrass rhizome) 100 g Asini Corii Colla (E Jiao \u002F Donkey-hide gelatin) 500 g",[13],"Drug: Ningshen Danxiang Donkey-hide Gelatin Medicated Paste",{"label":15,"type":16,"description":17,"interventionNames":18},"Ningshen Danxiang Agar Medicated Paste (agar as excipient)","PLACEBO_COMPARATOR","Formula Composition: Mori Fructus (Sang Shen \u002F Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi \u002F Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng \u002F Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi \u002F Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen \u002F Red sage root) 300 g Citri Medica Fructus (Xiang Yuan \u002F Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu \u002F Nutgrass rhizome) 100 g Agar 500 g",[19],"Drug: Ningshen Danxiang Agar Medicated Paste (agar as excipient)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Take 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals.",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"Xiaodan Zhang, Ph.D","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Chunyan Zhang, M.D.","CONTACT","021-58670561","6659","zhcy205@163.com",[40],{"facility":41,"status":25,"city":42,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Shanghai Seventh People's Hospital","Shanghai","Pudong New Area","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":36,"phoneExt":55,"email":56},"Yunduan Song, Ph.D","6730","qiyuankyc@163.com",{"type":31,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Xiaodan Zhang","Chief Physician",[61,63],{"name":62,"class":6},"Shanghai University of Traditional Chinese Medicine",{"name":64,"class":65},"DongE E Jiao Coporation Limited","INDUSTRY","100631734","phase-2-ning-shen-dan-xiang-gao-fang-for-heart-kidney-disharmony-insomnia-100631734",false,"NCT07504536","Ning Shen Dan Xiang Gao Fang for Heart-Kidney Disharmony Insomnia","A Randomized, Double-Blind, Dual-Control (Internal and External) Clinical Study of Ning Shen Dan Xiang Gao Fang in the Treatment of Insomnia (Heart-Kidney Disharmony Type)","Inclusion Criteria:\n\n1. Meets the diagnostic criteria for chronic insomnia and simultaneously meets the diagnostic criteria for heart-kidney disharmony syndrome.\n2. Pittsburgh Sleep Quality Index (PSQI) total score \\> 7 points.\n3. No insomnia treatment medication received within 2 weeks prior to the trial.\n4. Age \\> 18 years, gender unrestricted.\n5. Voluntarily participates in this study, signs the informed consent form, and is willing to take medication on time and undergo follow-up visits.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Patients with an allergic constitution or hypersensitivity to multiple drugs.\n3. Patients with primary diseases of the heart, liver, kidney, respiratory system, nervous system, hematopoietic system, or other systems, who are assessed by the investigator as unsuitable for participation in this study.\n4. Patients with schizophrenia, bipolar affective disorder, major depressive disorder (Hamilton Depression Rating Scale HAMD17 \\> 24 points), anxiety disorder (Hamilton Anxiety Rating Scale score ≥ 21 points), or other psychiatric disorders, as well as patients with senile dementia.\n5. Patients with insomnia induced by drugs, strong coffee\u002Ftea, or other substances, or those who have taken Chinese or Western medicines for the treatment of insomnia within 2 weeks prior to enrollment.\n6. History of alcohol or drug abuse.\n7. Laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 times the upper limit of the normal range, or creatinine (Cr) \\> the upper limit of the normal range.\n8. Patients who have participated in any other clinical trial within the past 3 months.\n9. Patients whom the investigator considers unsuitable for participation in this clinical trial.","ALL","18 Years",{"count":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","The goal of this clinical trial is to learn if Ning Shen Dan Xiang paste combined with Ejiao (donkey-hide gelatin) works better than Ning Shen Dan Xiang paste combined with agar (placebo substitute) to treat chronic insomnia of the heart-kidney disharmony type in adults. It will also assess safety. The main question is:\n\n\\- Does Ning Shen Dan Xiang + Ejiao improve sleep quality more than the placebo version, as shown by the change in Pittsburgh Sleep Quality Index (PSQI) score after 8 weeks?\n\nResearchers will compare the two pastes (identical in appearance and taste except for Ejiao) and use published literature data as an additional external control.\n\nParticipants will:\n\nTake 20 g of the assigned paste twice daily (morning and evening) for 8 weeks. Attend clinic visits at baseline, week 4, week 8, and 1 week after stopping (week 9 follow-up).\n\nComplete PSQI and ISI questionnaires, keep a daily electronic sleep diary, provide blood\u002Fstool samples, and undergo safety monitoring (blood\u002Furine tests, ECG, vital signs, and side effect checks).",[83],"Insomnia","NOT_YET_RECRUITING","2026-03-26",{"date":87,"type":88},"2026-04-01","ACTUAL",{"date":90,"type":77},"2026-03-15",{"date":92,"type":77},"2028-12-31",{"name":5,"class":6},1]