[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai 7th People's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26],"Insomnia","NOT_YET_RECRUITING","2026-03-26",{"date":30,"type":31},"2026-04-01","ACTUAL",{"date":33,"type":20},"2026-03-15",{"date":35,"type":20},"2028-12-31",{"name":37,"class":38},"Shanghai 7th People's Hospital","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100508526","acupuncture-and-escitalopram-for-treating-major-depression-clinical-study-100508526","NCT05901571","Acupuncture and Escitalopram for Treating Major Depression Clinical Study","Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial","AE-TMDCS","Inclusion Criteria:\n\n1. Between 18 and 75 years of age with no gender-based restriction.\n2. Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.\n3. A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17\n4. Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.\n5. The absence of acupuncture treatment within at least 1 year.\n6. Willingness to participate in the trial and provide written informed consent for the clinical trial.\n\nExclusion Criteria:\n\n1. Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.\n2. High suicide risk or presenting with suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry.\n3. Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.\n4. Pregnancy or breastfeeding.\n5. Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.\n6. Candidates afraid of needles in general and reluctant to receive acupuncture in particular\n7. Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).\n8. Previous participation in other acupuncture trials.","75 Years",{"count":50,"type":20},216,[52],"NA","We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.",[55],"Depressive Disorder, Major","2026-03-09",{"date":58,"type":31},"2026-03-11",{"date":60,"type":20},"2026-11",{"date":62,"type":20},"2030-02",{"name":37,"class":38},3,""]