NCT07698223Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 1 Mar 2027
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Chen Xiangmei
- Diseases
- Chronic kidney disease
- NCT number
- NCT07698223
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 410
- From 1 Mar 2027 to the primary completion date, 1 Jun 2028
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another drug or medical device clinical trial within the past 6 months.
Other illness
- 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.
- 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.
- 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).
Lab values
- Decline in eGFR of \> 30% within the past 3 months.
- Persistent serum potassium \> 5.5 mmol/L.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chinese PLA General Hospital First Medical Center Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Daping Hospital, Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Zhejiang Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| LongHua Hospital Shanghai University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.