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Study on the prevention and treatment of Yishen Xiaoyu prescription based on NLRP3/caspase-1/GSDMD pathway Clinical efficacy and mechanism of action in G2A3 diabetic kidney disease

Study on the prevention and treatment of Yishen Xiaoyu prescription based on NLRP3/caspase-1/GSDMD pathway Clinical efficacy and mechanism of action in G2A3 diabetic kidney disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000006
Enrollment
Unknown
Registered
2025-01-03
Start date
2025-02-05
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Diabetic kidney disease

Interventions

Control group:Western basic treatment +ARB drugs +SGLT-2i drugs
Chinese medicine group:Control group treatment + Yishen Xiaoyu prescription

Sponsors

Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for DKD in G2A3; the estimated glomerular filtration rate is 60-89ml/min and UACR is>300mg/g or 24-hour urine protein quantitation is> 0.5 g;2) TCM syndrome differentiation is syndrome of spleen and kidney deficiency and dampness and blood stasis blocking collaterals;3) Age is 18-75 years old regardless of gender;4) Blood pressure is stable below 160/90mmHg; 5) 6.5%= glycated hemoglobin =11.0%; 6) 18.0 kg/m2= Body mass index (BMI) = 40.0 kg/m2; 7) Voluntary participation and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Proteinuria caused by other reasons such as chronic glomerulonephritis systemic lupus erythematosus Sjogren's syndrome etc.2) Patients who develop diabetic ketoacidosis hyperosmolar syndrome (HHS) infection and severe diabetic foot gangrene within one month.3) The 24-hour urine protein quantitation is greater than 5.0 g or UACR is greater than 3000mg/g.4) Renovascular hypertension.5) Patients with a critical and severe history of malignant hypertension myocardial infarction cerebrovascular accident etc. within six months and patients with congestive heart failure grades I-IV.6) Cancer pregnancy and allergies to relevant drugs in the treatment plan are not suitable for receiving this treatment plan.7) Suggest possible conditions with diabetes mellitus and other kidney diseases: no retinopathy; rapid decrease in estimated glomerular filtration rate (eGFR); sharp increase in proteinuria or nephrotic syndrome; urinary sediment activity and increased formed elements; symptoms or signs of other systemic diseases (such as autoimmune diseases); eGFR decrease by>30% within 2 to 3 months after initiation of treatment with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor antagonists (ARBs); Abnormal renal function but no significant proteinuria; nephrotic syndrome lasts for a long time (more than 1 year) but normal renal function.8) Women during pregnancy or lactation. 9) Patients participating in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
urinary albumin to creatinine ratio;renal function;Cystatin C;TCM syndrome score;Quality of Life scores;

Secondary

MeasureTime frame
blood lipid;glycated hemoglobin A1c;Pyroptosis markers;serum interleukin 1ß;Fasting blood glucose;serum interleukin 6;

Countries

China

Contacts

Public ContactXie Shaofeng

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

xiesf3562@sina.com13951786203

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026