[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053358":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":118,"collaborators":26,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":26,"enrollmentInfo":132,"targetDuration":26,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":146,"whyStopped":26,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Naoxintong Capsule Group","EXPERIMENTAL","Participants will receive Naoxintong Capsules (4 capsules per dose, 3 times daily, orally, 30-60 minutes after meals) in addition to standard conventional therapy for diabetic nephropathy, for a total treatment duration of 12 months. Standard conventional therapy includes glycemic control (oral hypoglycemic agents and\u002For insulin), blood pressure management (ACEI or ARB, with optional non-RASI antihypertensives), lipid-lowering therapy (statins as indicated), dietary management (protein 0.6-0.8 g\u002Fkg\u002Fday, sodium \\\u003C3 g\u002Fday), and treatment of CKD-related complications as clinically indicated.",[13],"Drug: Naoxintong Capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants will receive matching placebo capsules (4 capsules per dose, 3 times daily, orally, 30-60 minutes after meals) in addition to standard conventional therapy for diabetic nephropathy, for a total treatment duration of 12 months. Standard conventional therapy is identical to that provided in the Naoxintong group.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Naoxintong Capsule","Naoxintong Capsule is a traditional Chinese medicine formulation composed of 16 herbal and animal-derived ingredients: Astragalus membranaceus (Huangqi), Prunus persica seed (Taoren), Carthamus tinctorius flower (Honghua), Paeonia lactiflora root (Chishao), Angelica sinensis root (Danggui), Ligusticum chuanxiong rhizome (Chuanxiong), Boswellia carterii resin (Ruxiang), Commiphora myrrha resin (Moyao), Salvia miltiorrhiza root (Danshen), Achyranthes bidentata root (Niuxi), Cinnamomum cassia twig (Guizhi), Morus alba twig (Sangzhi), Spatholobus suberectus stem (Jixueteng), Buthus martensii (Quanxie), Pheretima aspergillum (Dilong), and Hirudo nipponica (Shuizhi). Each capsule contains 0.4 g of active ingredients. Dosage: 4 capsules (1.6 g) per dose, taken orally 3 times daily, 30-60 minutes after meals. Manufactured by Shaanxi Buchang Pharmaceutical Co., Ltd. (National Drug Approval No.: Guoyaozhunzi Z20025001). Storage: sealed, at room temperature. Shelf life: 24 months.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Matching placebo capsules identical in appearance, size, shape, color, weight, packaging, and labeling to Naoxintong Capsules but containing no active pharmaceutical or herbal ingredients. Dosage: 4 capsules per dose, taken orally 3 times daily, 30-60 minutes after meals. Manufactured by Shaanxi Buchang Pharmaceutical Co., Ltd. Storage: sealed, at room temperature. Shelf life: 24 months.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Zheyi Dong, MD","CONTACT","010-66937763","shengdai26@163.com",[38,53,60,71,82,93,100,107],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Chinese PLA General Hospital, First Medical Center","Beijing","Beijing Municipality","100853","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"facility":54,"status":26,"city":40,"state":41,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"China-Japan Friendship Hospital",{"type":46,"coordinates":56},[48,49],{"lat":49,"lon":48},[59],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"facility":61,"status":26,"city":62,"state":63,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Daping Hospital, Army Medical University","Chongqing","Chongqing Municipality",{"type":46,"coordinates":65},[66,67],106.55771,29.56026,{"lat":67,"lon":66},[70],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"facility":72,"status":26,"city":73,"state":74,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"First Affiliated Hospital of Dalian Medical University","Dalian","Liaoning",{"type":46,"coordinates":76},[77,78],121.60222,38.91222,{"lat":78,"lon":77},[81],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"facility":83,"status":26,"city":84,"state":85,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Longhua Hospital, Shanghai University of Traditional Chinese Medicine","Shanghai","Shanghai Municipality",{"type":46,"coordinates":87},[88,89],121.45806,31.22222,{"lat":89,"lon":88},[92],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"facility":94,"status":26,"city":84,"state":85,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"Renji Hospital, Shanghai Jiao Tong University School of Medicine",{"type":46,"coordinates":96},[88,89],{"lat":89,"lon":88},[99],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"facility":101,"status":26,"city":84,"state":85,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine",{"type":46,"coordinates":103},[88,89],{"lat":89,"lon":88},[106],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"facility":108,"status":26,"city":109,"state":110,"zip":26,"country":43,"countryCode":44,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Zhejiang Provincial Hospital of Traditional Chinese Medicine","Hangzhou","Zhejiang",{"type":46,"coordinates":112},[113,114],120.16142,30.29365,{"lat":114,"lon":113},[117],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":119,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Chen Xiangmei","Professor","100053358","phase-4-naoxintong-capsule-for-diabetic-nephropathy-with-dampness-retention-pattern-a-multicenter-randomized-double-blind-placebo-controlled-trialacronymnxt-dkd-100053358",false,"NCT07698223","Naoxintong Capsule for Diabetic Nephropathy With Dampness Retention Pattern: A Multicenter, Randomized, Double-Blind, Placebo-Controlled TrialAcronymNXT-DKD","Evidence-Based Evaluation of Naoxintong Capsule in the Treatment of Diabetic Nephropathy With Dampness Retention Pattern: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial","NXT-DKD","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Meets the diagnostic criteria for Type 2 diabetic nephropathy, defined as:\n\n   1. Confirmed diagnosis of Type 2 diabetes mellitus; AND\n   2. At least one of the following: urinary albumin-to-creatinine ratio (UACR) \\>= 30 mg\u002Fg, or eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2, confirmed by repeat testing (interval \\>= 3 months), after excluding transient factors such as acute kidney injury, dehydration, infection, or heart failure; OR\n   3. Renal biopsy confirmed as isolated diabetic nephropathy; AND\n   4. Exclusion of other primary or secondary kidney diseases.\n3. 24-hour urinary protein excretion \\>= 0.5 g and \\\u003C 3.5 g.\n4. Estimated glomerular filtration rate (eGFR) \\>= 45 mL\u002Fmin\u002F1.73m\\^2.\n5. On a stable dose of ACE inhibitor (ACEI) or Angiotensin II receptor blocker (ARB) therapy for at least 8 weeks prior to enrollment. If SGLT2 inhibitors, mineralocorticoid receptor antagonists (MRA), or GLP-1 receptor agonists are being used, the dose must have been stable for at least 4 weeks prior to enrollment and remain unchanged during the study period. Patients not currently using these agents must not initiate them during the study.\n6. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus or other types of diabetes mellitus (e.g., secondary diabetes, maturity-onset diabetes of the young).\n2. Coexisting systemic autoimmune or immune-mediated disease where the clinical assessment suggests a non-diabetic nephropathy etiology.\n3. Decline in eGFR of \\> 30% within the past 3 months.\n4. Persistent serum potassium \\> 5.5 mmol\u002FL.\n5. Diagnosis of hemorrhagic cardiovascular or cerebrovascular disease within the past 3 months.\n6. Known allergy or hypersensitivity to any component of Naoxintong Capsule or placebo; pregnant or lactating women.\n7. Participation in another drug or medical device clinical trial within the past 6 months.\n8. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in the clinical trial (e.g., severe hepatic dysfunction, life expectancy \\\u003C 1 year).","ALL","18 Years",{"count":133,"type":134},410,"ESTIMATED","INTERVENTIONAL",[137],"PHASE4","Diabetic nephropathy (DN) is a leading cause of end-stage kidney disease worldwide and is associated with a high risk of cardiovascular events and mortality. Despite current standard therapies including renin-angiotensin system inhibitors (ACEI\u002FARB), glycemic control, and blood pressure management, disease progression remains inadequately controlled in many patients.\n\nNaoxintong Capsule is a traditional Chinese medicine formulation composed of 16 herbal ingredients (Astragalus membranaceus, Prunus persica seed, Carthamus tinctorius, Paeonia lactiflora, Angelica sinensis, Ligusticum chuanxiong, Boswellia carterii, Commiphora myrrha, Salvia miltiorrhiza, Achyranthes bidentata, Cinnamomum cassia, Morus alba, Spatholobus suberectus, Buthus martensii, Pheretima aspergillum, and Hirudo nipponica). It has been widely used in China for cardiovascular and cerebrovascular diseases, with demonstrated effects on endothelial protection, anti-inflammation, anti-thrombosis, and plaque stabilization.\n\nThis multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Naoxintong Capsule added to standard conventional therapy in slowing the progression of diabetic nephropathy and providing cardiovascular protection. A total of 410 patients with Type 2 diabetic nephropathy will be randomized (1:1) to receive either Naoxintong Capsules (4 capsules, 3 times daily) or matching placebo, in addition to standard therapy, for 12 months. The primary outcome is the annual rate of decline in estimated glomerular filtration rate (eGFR). Secondary outcomes include changes in proteinuria, CKD stage progression, time to end-stage kidney disease, major adverse cardiovascular events, TCM syndrome scores, and quality of life measures.",[140],"Diabetic Nephropathy",[142,140,23,143,144,145],"Diabetic Kidney Disease","Traditional Chinese Medicine","Dampness Retention Pattern","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-08",{"date":149,"type":150},"2026-07-13","ACTUAL",{"date":152,"type":134},"2027-03-01",{"date":154,"type":134},"2028-12-30",{"name":120,"class":6},8]