Diabetic Kidney Disease
Conditions
Interventions
High-risk Qi Kui granules group:Basic treatment plus Qi Kui granules
High-risk control group:Basic treatment
Moderate-risk Jiahua tablet group:Basic treatment plus Jiahua tablets
Moderate-risk control group:Basic treatment
Sponsors
Jiangsu Province Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for DKD; 2. eGFR is =30 ml/min/1.73m²; 3. Traditional Chinese Medicine (TCM) syndrome differentiation matches the main patterns described in the above stages; 4. Age between 30-75 years gender not limited; 5. Blood pressure is stable below 160/90 mmHg; 6. Glycated hemoglobin (HbA1c) is =9%; 7. Informed consent.
Exclusion criteria
Exclusion criteria: 1 Proteinuria caused by other reasonssuch as chronic glomerulonephritissystemic lupus erythematosusSjögren's syndromeetc. 2Diabetic ketoacidosishyperosmolar hyperglycemic state(HHS)infectionsevere diabetic foot gangrene within one month. 3Urinary protein quantification greater than 6g/24hr. 4 Renovascular hypertension. 5 History of malignant hypertensionmyocardial infarctioncerebrovascular accidentsor other critical conditions within six monthsor those with congestive heart failure grades I-IV. 6Cancerpregnancyand those allergic to drugs in the treatment plan who are not suitable for this treatment regimen. 7Indications that may suggest diabetes combined with other kidney diseases:absence of retinopathy;rapid decline in GFR;sudden increase in proteinuria or the appearance of nephrotic syndrome;active urinary sediment with increased formed elements;symptoms or signs of other systemic diseases(such as autoimmune diseases);more than 30%decline in GFR within 2-3 months after starting treatment with angiotensin-co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR;Serum Creatinine;Urea;24hUTP;Cystatin C; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom and Sign Score Changes;Endpoint Events: Dialysis Event Rate;Mortality Event Rate;Endpoint Events: Cardiovascular and Cerebrovascular Event Rate;Traditional Chinese Medicine Syndrome Efficacy;Serum NLRP3;Urinary Caspase-1;Urinary NLRP3;Urinary IL-1ß;Endpoint Events: Creatinine Doubling Rate;Quality of Life Assessment;Serum Caspase-1;Serum IL-1ß; | — |
Countries
CHINA
Contacts
Public ContactLiJiHuang
Jiangsu Province Hospital of Traditional Chinese Medicine
Outcome results
None listed