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

NCT07698223 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Chen Xiangmei

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2028-06-01
Completion
2028-12-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698223 on ClinicalTrials.gov