[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652310":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":154,"collaborators":37,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":37,"eligibilityCriteria":163,"healthyVolunteers":164,"sex":165,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":37,"studyType":171,"phases":172,"briefSummary":174,"conditions":175,"keywords":181,"overallStatus":187,"whyStopped":37,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Hepatopancreatobiliary Surgery Institute of Gansu Province","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Combination product group","EXPERIMENTAL","Bao Yuan Tang full-component extract (2.0g) and galactooligosaccharides (2.0g).",[13],"Dietary Supplement: Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g)",{"label":15,"type":16,"description":17,"interventionNames":18},"Bao Yuan Tang group","ACTIVE_COMPARATOR","Bao Yuan Tang full-component extract (2.0g) plus a placebo consisting of maltodextrin (2.0g).",[19],"Dietary Supplement: Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g",{"label":21,"type":16,"description":22,"interventionNames":23},"Galactooligosaccharides group","galactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g).",[24],"Dietary Supplement: Galactooligosaccharides 2.0g",{"label":26,"type":27,"description":28,"interventionNames":29},"Placebo control group","PLACEBO_COMPARATOR","maltodextrin placebo (4.0g).",[30],"Other: maltodextrin placebo 4.0g",[32,38,42,46],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DIETARY_SUPPLEMENT","Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g)","Participants will receive a combination product consisting of Bao Yuan Tang full-component extract (2.0g) and galactooligosaccharides (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.",[9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g","Participants will receive Bao Yuan Tang full-component extract (2.0g) plus a placebo consisting of maltodextrin (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.",[15],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Galactooligosaccharides 2.0g","Participants will receive galactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.",[21],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"maltodextrin placebo 4.0g","Participants will receive maltodextrin placebo (4.0g), administered twice daily, one sachet each time, for 3 weeks.",[26],[51],{"name":52,"affiliation":53,"role":54},"Wenbo Meng, M.D., Ph.D.","LanZhou University","PRINCIPAL_INVESTIGATOR",[56,60],{"name":52,"role":57,"phone":58,"phoneExt":37,"email":59},"CONTACT","+8613919177177","mengwb@lzu.edu.cn",{"name":61,"role":57,"phone":62,"phoneExt":37,"email":63},"Liang Tian, M.D.","+8615293146623","tianl2024@lzu.edu.cn",[65,83,94,109,124,139],{"facility":66,"status":37,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"The First Hospital of Lanzhou University","Lanzhou","Gansu","730000","China","CN",{"type":73,"coordinates":74},"Point",[75,76],103.83987,36.05701,{"lat":76,"lon":75},[79],{"name":80,"role":57,"phone":81,"phoneExt":37,"email":82},"Huaping Wei, MSN","+8613893146855","1521583371@qq.com",{"facility":84,"status":37,"city":67,"state":68,"zip":85,"country":70,"countryCode":71,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"The Second Hospital & Clinical Medical School, Lanzhou University","730030",{"type":73,"coordinates":87},[75,76],{"lat":76,"lon":75},[90],{"name":91,"role":57,"phone":92,"phoneExt":37,"email":93},"Xinman Dou, Ph.D","+8613909318916","douxm@lzu.edu.cn",{"facility":95,"status":37,"city":96,"state":97,"zip":98,"country":70,"countryCode":71,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"The Fourth Affiliated Hospital of Hebei University of Traditional Chinese Medicine","Shijiazhuang","Hebei","050031",{"type":73,"coordinates":100},[101,102],114.47861,38.04139,{"lat":102,"lon":101},[105],{"name":106,"role":57,"phone":107,"phoneExt":37,"email":108},"Hu Chen, M.D.","+8613933139501","565302759@qq.com",{"facility":110,"status":37,"city":111,"state":112,"zip":113,"country":70,"countryCode":71,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Xiangyang Central Hospital","Xiangyang","Hubei","441000",{"type":73,"coordinates":115},[116,117],112.14479,32.0422,{"lat":117,"lon":116},[120],{"name":121,"role":57,"phone":122,"phoneExt":37,"email":123},"Xiaohong Zhang, MSN","+8613972256041","1207004166@qq.com",{"facility":125,"status":37,"city":126,"state":127,"zip":128,"country":70,"countryCode":71,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"The Seventh Affiliated Hospital of Xinjiang Medical University","Ürümqi","Xinjiang","830028",{"type":73,"coordinates":130},[131,132],87.60046,43.80096,{"lat":132,"lon":131},[135],{"name":136,"role":57,"phone":137,"phoneExt":37,"email":138},"Xing Wu, MSN","+8618099186318","1484597330@qq.com",{"facility":140,"status":37,"city":141,"state":142,"zip":143,"country":70,"countryCode":71,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"The First People's Hospital of Yunnan Province","Kunming","Yunnan","650832",{"type":73,"coordinates":145},[146,147],102.71833,25.03889,{"lat":147,"lon":146},[150],{"name":151,"role":57,"phone":152,"phoneExt":37,"email":153},"Yi Dai, Ph.D","+8615887800809","179087201@qq.com",{"type":54,"investigatorFullName":155,"investigatorTitle":156,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Wenbo Meng","M.D., Ph.D.","100652310","bao-yuan-tang-extract-and-galactooligosaccharides-for-sleep-regulation-100652310",false,"NCT07774897","Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation","Sleep-Promoting Effects of Bao Yuan Tang Whole-Component Extract Combined With Galactooligosaccharides: A Prospective, Multicenter, Triple-blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Female registered nurses aged 25-45 years.\n* Participants must meet at least one of the following criteria, self-reported presence of at least one target symptom of the trial, including insomnia, daytime fatigue, or difficulty initiating sleep or Pittsburgh Sleep Quality Index (PSQI) score \\>7.\n* Engagement in shift work for at least one month before enrollment, with either ≥ 4 night shifts or ≥32 hours of night-shift work during the preceding month.\n\nExclusion Criteria:\n\n* Diagnosed with type 1 or type 2 diabetes mellitus and currently receiving pharmacological treatment.\n* Diagnosed with clinically thyroid dysfunction, including hyperthyroidism or hypothyroidism, and currently receiving pharmacological treatment.\n* Diagnosed with Cushing's syndrome, pituitary dysfunction, or other clearly defined endocrine disorders.\n* Diagnosed with polycystic ovary syndrome (PCOS) and currently receiving pharmacological treatment.\n* Use of medications that may affect study outcomes, including oral contraceptives, glucose-lowering agents, hormonal medications, hypnotics, lipid-regulating agents, or thyroid hormone preparations, within the past 3 months.\n* Pregnancy, lactation, or planned pregnancy during the study period.\n* Confirmed severe organic diseases, such as hepatic or renal insufficiency, cardiovascular disease, or malignancy.\n* Known allergy to any component of the investigational product.\n* Use of probiotics, prebiotics, or related traditional Chinese medicine preparations within the past 1 month.\n* Participation in another clinical trial within the past 3 months.\n* Planned engagement in vigorous exercise or a weight-management program during the study period.\n* A previous diagnosis of psychiatric disorders, such as anxiety or depression.\n* Any condition judged by the investigator to involve communication difficulties, poor compliance, or potential interference with adherence to the study protocol.",true,"FEMALE","25 Years","45 Years",{"count":169,"type":170},400,"ESTIMATED","INTERVENTIONAL",[173],"NA","Certain classical formulas in traditional Chinese medicine and dietary prebiotics have demonstrated beneficial effects on various aspects of suboptimal health status in previous studies. This research aims to evaluate the effects of Bao Yuan Tang full-component extract combined with galactooligosaccharides on improving health-related outcomes in female registered nurse with suboptimal health status, including sleep disturbances, fatigue, endocrine dysregulation, and glucose and lipid metabolic abnormalities.",[176,177,178,179,180],"Sleep Disturbance","Fatigue Syndrome, Chronic","Endocrine Disorder","Glucose Metabolism Disorder","Lipid Metabolism Disorders",[182,183,184,185,186],"Bao Yuan Tang full-component extract","Galactooligosaccharides","Sleep quality","Prebiotic","Metabolic health","NOT_YET_RECRUITING","2026-08-16",{"date":190,"type":191},"2026-08-19","ACTUAL",{"date":193,"type":170},"2026-09-30",{"date":195,"type":170},"2027-09-30",{"name":5,"class":6},6]