[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554099":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":65,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":35,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":35,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":57,"whyStopped":35,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Jiangxi University of Traditional Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pueraria lobata radix group","EXPERIMENTAL","Pueraria lobata radix will be made into granules.",[13],"Drug: Pueraria lobata radix",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","The dosage form, specifications and packaging of the placebo will be no different from those of Pueraria lobata radix granules, and the smell and taste will be basically the same.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pueraria lobata radix","The dose of Pueraria lobata radix granules is one sachet per day, 1.5g per sachet, which equivalent to 15 g of the original herb.",[15,9],[26],"Ge Gen",[28],{"name":29,"affiliation":5,"role":30},"Xu Zhou, M.D","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","+8618870050733",null,"zhouxu_ebm@hotmail.com",[38,55],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The First Affiliated Hospital of Nanchang University","NOT_YET_RECRUITING","Nanchang","Jiangxi","330004","China","CN",{"type":47,"coordinates":48},"Point",[49,50],115.85306,28.68396,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":35,"phoneExt":35,"email":35},"Jianrong Chen",{"facility":56,"status":57,"city":41,"state":42,"zip":58,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine","RECRUITING","330006",{"type":47,"coordinates":60},[49,50],{"lat":50,"lon":49},[63],{"name":64,"role":33,"phone":35,"phoneExt":35,"email":35},"Zhengfeng Li",{"type":30,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Xu Zhou","Professor",[69,70],{"name":56,"class":6},{"name":39,"class":6},"100554099","efficacy-and-safety-of-pueraria-lobata-radix-as-an-adjuvant-treatment-for-type-2-diabetes-mellitus-100554099",false,"NCT06494683","Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus","Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of type 2 diabetes mellitus according to the International Diabetes Guidelines: fasting blood glucose (FBG) ≥ 126 mg\u002Fdl (7.0 mmol\u002Fl) or 2-hour postprandial blood glucose ≥ 200 mg\u002FdL (11.1 mmol\u002Fl), or HbA1c ≥ 6.5% (48 mmol\u002Fmol).\n2. Age between 18 and 80 years old.\n3. Untreated patients or those currently receiving regular anti-diabetic medication therapy, including oral hypoglycemic drugs and insulin, with no restrictions on types or doses.\n4. Blood glucose levels not effectively controlled in the three months prior to baseline screening: HbA1c between 6.5% and 10.5%.\n5. Willingness to comply with dietary control requirements during the study.\n6. Voluntary participation and signing of informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes, gestational diabetes, and special types of diabetes.\n2. History of diabetic acute complications, including ketoacidosis, hyperosmolar coma, and lactic acidosis.\n3. Pregnant or lactating women, or women planning pregnancy.\n4. Allergy history to Pueraria lobata radix.\n5. Severe dysfunction of vital organs such as heart, liver, and kidney, malignant tumors, or severe mental disorders.\n6. Anticipated poor compliance or language communication impairments.\n7. Currently participating in other clinical trials.","ALL","18 Years","80 Years",{"count":82,"type":83},200,"ESTIMATED","INTERVENTIONAL",[86],"NA","As a dietary herb, pueraria lobata radix (PLR) has been showed to have hypoglycemic effects in animal experiments. However, there is currently a lack of evidence from randomized controlled trials. Therefore, this randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of PLR as an adjunctive treatment for type 2 diabetes mellitus (T2DM).",[89],"Type 2 Diabetes Mellitus",[22,26,91,92],"Type 2 diabetes mellitus","Randomized controlled trial","2025-02-19",{"date":95,"type":96},"2025-02-21","ACTUAL",{"date":98,"type":96},"2024-07-25",{"date":100,"type":83},"2025-12-30",{"name":5,"class":6},2]