A randomized, double-blind, placebo-controlled, multi-center clinical trial of Keluoxin Capsule in the treatment of early diabetic nephropathy (qi and yin deficiency and blood stasis syndrome)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052764

Enrollment

Unknown

Registered

2021-11-05

Start date

2014-06-02

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DKD

Interventions

experimental group:Basic treatment + Keluoxin Capsule

control group:Basic treatment + placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of western medicine for type 2 diabetes. 2. Meet the diagnostic criteria of early diabetic nephropathy (equivalent to stage III of Mogensen staging). 3. Aged 18-70 years, regardless of gender. 4. Blood pressure <140/90mmHg, glycosylated hemoglobin <= 7.5%. 5. TCM syndromes are those with deficiency of both qi and yin and blood stasis. 6. Those who voluntarily participate in the experimental research and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with renal artery stenosis and renal vascular hypertension. 2. Women who are pregnant or breast-feeding or have birth plans. 3. Disabled patients (blind, deaf, dumb, physical disability) prescribed by law. 4. People with mental or intellectual disabilities. 5. Patients with severe heart and lung system diseases and chronic liver and kidney dysfunction, including blood ALT, AST > The upper limit of normal. 6. Those who are allergic or allergic to the test drug ingredients. 7. Those who cannot accept the diet of diabetic nephropathy. 8. Risks of malignant hypertension, myocardial infarction, cerebrovascular accident, diabetic ketoacidosis, etc. within six months Patients with a history of acute and severe illness, or patients with congestive heart failure grade I-IV, and patients with chronic diarrhea. 9. Primary or secondary kidney disease (chronic nephritis, hypertension, gout, lupus erythematosus, etc.) Those with increased urinary microalbumin or urinary protein excretion rate. 10. Participants in other clinical trials within 1 month before enrollment.

Design outcomes

Primary

Measure	Time frame
urinary albumin / creatinine ratio;	—

Secondary

Measure	Time frame
TCM symptom score;Quality of life assessment;serum creatinine and glomerular filtration rate;	—

Countries

China

Contacts

Public ContactZhao Jinxi

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

zhaojinximd@126.com+86 10 84013361

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026