[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554099":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":86,"studyPopulation":74,"armGroups":87,"interventions":99,"overallOfficials":107,"centralContacts":111,"locations":116,"responsibleParty":144,"collaborators":147,"id":150,"slug":74,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":74,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":74,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":136,"whyStopped":74,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Jiangxi University of Traditional Chinese Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":74},[9],{"measure":10,"description":11,"timeFrame":12},"HbA1c","Changes from baseline in HbA1c levels","Baseline and Week 12",[14,16,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71],{"measure":10,"description":11,"timeFrame":15},"Baseline, Week 4 and Week 8",{"measure":17,"description":18,"timeFrame":19},"HbA1c response rate","Proportion of patients with HbA1c \\\u003C 7.0%","Baseline, Week 4, Week 8 and Week 12",{"measure":21,"description":22,"timeFrame":19},"Fasting blood glucose","Changes from baseline in fasting blood glucose levels",{"measure":24,"description":25,"timeFrame":19},"Two-hour postprandial glucose","Changes from baseline in two-hour postprandial glucose levels",{"measure":27,"description":28,"timeFrame":19},"Fasting C-peptide","Changes from baseline in fasting C-peptide levels",{"measure":30,"description":31,"timeFrame":19},"Body mass index","Changes from baseline in body mass index",{"measure":33,"description":34,"timeFrame":12},"Total cholesterol","Changes from baseline in total cholesterol levels",{"measure":36,"description":37,"timeFrame":12},"Triglycerides","Changes from baseline in triglycerides levels",{"measure":39,"description":40,"timeFrame":12},"High-density lipoprotein cholesterol","Changes from baseline in high-density lipoprotein cholesterol levels",{"measure":42,"description":43,"timeFrame":12},"Low-density lipoprotein cholesterol","Changes from baseline in low-density lipoprotein cholesterol levels",{"measure":45,"description":46,"timeFrame":12},"Non-high-density lipoprotein cholesterol","Changes from baseline in non-high-density lipoprotein cholesterol levels",{"measure":48,"description":49,"timeFrame":19},"Systolic blood pressure","Changes from baseline in systolic blood pressure",{"measure":51,"description":52,"timeFrame":19},"Diastolic blood pressure","Changes from baseline in diastolic blood pressure",{"measure":54,"description":55,"timeFrame":19},"Severity of diabetes symptoms","Severity of diabetes symptoms will be scored using the Diabetes Symptom Grading Scale in the \"Guiding Principles of Clinical Research on New Drugs of Traditional Chinese Medicines\".",{"measure":57,"description":58,"timeFrame":19},"Diabetes Specific Quality of Life questionnaire scores","Quality of life will be measured using the Diabetes Specific Quality of Life questionnaire (DSQL).",{"measure":60,"description":61,"timeFrame":19},"Hypoglycemic drug dose","Changes from baseline in hypoglycemic drug dose",{"measure":63,"description":64,"timeFrame":19},"Incidence of any adverse events","An adverse event is defined as any medically induced harm, excluding those due to nature progression of diabetes mellitus.",{"measure":66,"description":67,"timeFrame":19},"Incidence of severe adverse events","Severe adverse events include adverse events that require hospitalization, induce prolonged hospitalization, disability, or impacts on work capacity, are life-threatening, or cause death.",{"measure":69,"description":70,"timeFrame":19},"Incidence of treatment-related adverse events","The causality of treatment and adverse events will be assessed by the Clinical Event Committee.",{"measure":72,"description":73,"timeFrame":19},"Incidence of individual adverse events","The main concern is hypoglycemia and gastrointestinal reactions.",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":74,"primaryPurpose":78,"observationalModel":74,"timePerspective":74,"maskingInfo":79},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":80,"maskingDescription":74,"whoMasked":81},"QUADRUPLE",[82,83,84,85],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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).\n\nT2DM is the most prevalent chronic metabolic disease. It has been noted in clinical practice that the limitations of conventional treatment methods, such as secondary failure and adverse reactions, continue to pose challenges for patients in managing their blood glucose levels, preventing them from achieving optimal glycemic control goals. Therefore, it is essential to search for more effective and safe complementary medications.\n\nPLR (Chinese name: Ge Gen) is the dried root of the leguminous plant kudzu (Pueraria lobata (Willd.) Ohwi). In China and other East Asian countries, PLR has been widely used to treat metabolic diseases, including T2DM. The chemical components of PLR include isoflavones, triterpenes, saponins, polysaccharides, coumarin compounds, and alkaloids, with isoflavones being the primary active ingredients of PLR. Multiple animal studies have shown that the main active components in isoflavones, such as puerarin, daidzein, and genistein, effectively increase serum insulin concentrations, lower blood glucose levels, and improve insulin resistance in diabetic mice. Puerarin injection has been widely used in China for the treatment of diabetes and its complications.\n\nPLR is classified as a medicinal and edible herb according to Chinese regulations, demonstrating good safety, with no reports of adverse reactions from long-term consumption in practice. However, there is currently a lack of randomized controlled trial evidence on the use of PLR for assisting in glycemic management. Therefore, this study aims to conduct a randomized controlled trial to evaluate the efficacy and safety of daily PLR treatment for adjunctive management of T2DM.",[88,94],{"label":89,"type":90,"description":91,"interventionNames":92},"Pueraria lobata radix group","EXPERIMENTAL","Pueraria lobata radix will be made into granules.",[93],"Drug: Pueraria lobata radix",{"label":95,"type":96,"description":97,"interventionNames":98},"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.",[93],[100],{"type":101,"name":102,"description":103,"armGroupLabels":104,"otherNames":105},"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.",[95,89],[106],"Ge Gen",[108],{"name":109,"affiliation":5,"role":110},"Xu Zhou, M.D","PRINCIPAL_INVESTIGATOR",[112],{"name":109,"role":113,"phone":114,"phoneExt":74,"email":115},"CONTACT","+8618870050733","zhouxu_ebm@hotmail.com",[117,134],{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":131},"The First Affiliated Hospital of Nanchang University","NOT_YET_RECRUITING","Nanchang","Jiangxi","330004","China","CN",{"type":126,"coordinates":127},"Point",[128,129],115.85306,28.68396,{"lat":129,"lon":128},[132],{"name":133,"role":113,"phone":74,"phoneExt":74,"email":74},"Jianrong Chen",{"facility":135,"status":136,"city":120,"state":121,"zip":137,"country":123,"countryCode":124,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine","RECRUITING","330006",{"type":126,"coordinates":139},[128,129],{"lat":129,"lon":128},[142],{"name":143,"role":113,"phone":74,"phoneExt":74,"email":74},"Zhengfeng Li",{"type":110,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"Xu Zhou","Professor",[148,149],{"name":135,"class":6},{"name":118,"class":6},"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":160,"type":161},200,"ESTIMATED","INTERVENTIONAL",[164],"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).",[167],"Type 2 Diabetes Mellitus",[102,106,169,170],"Type 2 diabetes mellitus","Randomized controlled trial","2025-02-19",{"date":173,"type":174},"2025-02-21","ACTUAL",{"date":176,"type":174},"2024-07-25",{"date":178,"type":161},"2025-12-30",{"name":5,"class":6},2]