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

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Diabetic Nephropathy

In brief

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.

Key facts

Study ID

NCT07698223

Run by

Chen Xiangmei

People needed

410

Starts

2027-03-01

Expected to finish

2028-12-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >= 18 years.
• Meets the diagnostic criteria for Type 2 diabetic nephropathy, defined as:
• Confirmed diagnosis of Type 2 diabetes mellitus; AND
• 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
• Renal biopsy confirmed as isolated diabetic nephropathy; AND
• Exclusion of other primary or secondary kidney diseases.
• 24-hour urinary protein excretion >= 0.5 g and < 3.5 g.
• Estimated glomerular filtration rate (eGFR) >= 45 mL/min/1.73m\^2.
• 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.
• Signed informed consent form.

You may not qualify if…

• Type 1 diabetes mellitus or other types of diabetes mellitus (e.g., secondary diabetes, maturity-onset diabetes of the young).
• Coexisting systemic autoimmune or immune-mediated disease where the clinical assessment suggests a non-diabetic nephropathy etiology.
• Decline in eGFR of > 30% within the past 3 months.
• Persistent serum potassium > 5.5 mmol/L.
• Diagnosis of hemorrhagic cardiovascular or cerebrovascular disease within the past 3 months.
• Known allergy or hypersensitivity to any component of Naoxintong Capsule or placebo; pregnant or lactating women.
• Participation in another drug or medical device clinical trial within the past 6 months.
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.