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NCT07698223

PHASE4

Naoxintong Capsule for Diabetic Nephropathy With Dampness Retention Pattern: A Multicenter, Randomized, Double-Blind, Placebo-Controlled TrialAcronymNXT-DKD

Sponsor: Chen Xiangmei

View on ClinicalTrials.gov

Summary

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/ARB), glycemic control, and blood pressure management, disease progression remains inadequately controlled in many patients. Naoxintong 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. This 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2027-03-01

Completion Date

2028-12-30

Last Updated

2026-07-13

Healthy Volunteers

Conditions

Diabetic Nephropathy

Interventions

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.

DRUG

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.

Inclusion Criteria: 1. Age \>= 18 years. 2. Meets the diagnostic criteria for Type 2 diabetic nephropathy, defined as: 1. Confirmed diagnosis of Type 2 diabetes mellitus; AND 2. At least one of the following: urinary albumin-to-creatinine ratio (UACR) \>= 30 mg/g, or eGFR \< 60 mL/min/1.73m\^2, confirmed by repeat testing (interval \>= 3 months), after excluding transient factors such as acute kidney injury, dehydration, infection, or heart failure; OR 3. Renal biopsy confirmed as isolated diabetic nephropathy; AND 4. Exclusion of other primary or secondary kidney diseases. 3. 24-hour urinary protein excretion \>= 0.5 g and \< 3.5 g. 4. Estimated glomerular filtration rate (eGFR) \>= 45 mL/min/1.73m\^2. 5. 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. 6. Signed informed consent form. Exclusion Criteria: 1. Type 1 diabetes mellitus or other types of diabetes mellitus (e.g., secondary diabetes, maturity-onset diabetes of the young). 2. Coexisting systemic autoimmune or immune-mediated disease where the clinical assessment suggests a non-diabetic nephropathy etiology. 3. Decline in eGFR of \> 30% within the past 3 months. 4. Persistent serum potassium \> 5.5 mmol/L. 5. Diagnosis of hemorrhagic cardiovascular or cerebrovascular disease within the past 3 months. 6. Known allergy or hypersensitivity to any component of Naoxintong Capsule or placebo; pregnant or lactating women. 7. Participation in another drug or medical device clinical trial within the past 6 months. 8. 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 \< 1 year).

Locations (8)

Chinese PLA General Hospital, First Medical Center

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, China

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, China

Clinical Research Directory

Naoxintong Capsule for Diabetic Nephropathy With Dampness Retention Pattern: A Multicenter, Randomized, Double-Blind, Placebo-Controlled TrialAcronymNXT-DKD

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (8)