To investigate the efficacy and safety of Sanhuangtangshenkang（三黄糖肾康）combined with Dapagliflozin in the treatment of Qi deficiency and blood stasis type of early diabetic nephropathy（DN）.

A randomized，double-blind and placebo-controlled clinical trial was conducted involving 120 patients from the Endocrinology and Nephrology Departments at Taizhou Hospital of Traditional Chinese Medicine from June 2021 to June 2023.The participants were allocated into two groups.The experimental group（60 patients）received standard care augmented with Sanhuangtangshenkang and Dapagliflozin，while the control group（60 patients）was treated with standard care plus placebo granules and Dapagliflozin.The duration of treatmentwas 12 weeks.The primary endpoints included the efficacy of treatment，the renal function，the inflammatory markers，the enhancement of traditional Chinese medicine（TCM）syndromes，and the frequency of adverse events.

A total of 117 patients were successfully enrolled，59 in the experimental group and 58 in the control group.The experimental group showed a significantly higher overall effective rate compared to the control group（98.30% versus70.68%，P<0.05）.Biochemical indicators such as the urine albumin-to-creatinine ratio（UACR），24-hour urinary microalbumin（UMA）and 24-hour urinary protein were significantly improved in the experimental group compared to those in the control group after 12 weeks of treatment（P<0.05）.Inflammatory markers including serum amyloid A（SAA），interleukin-6（IL-6），C-reactive protein（CRP）and homocysteine（Hcy）also showed more significant reductions in the experimental group，especially after 12 weeks of treatment（P<0.05）.The improvements in renal function and other biochemical indicators，such as glycated hemoglobin（HbA1c），estimated glomerular filtration rate（eGFR）and total cholesterol（TC），were also notably better in the experimental group（P<0.05）.TCM symptom scores further confirmed the improvement in various indicators in the experimental group after treatment（P<0.05）.Although there was no statistically significant difference in the incidence of adverse reactions between the two groups（P>0.05）.The experimental group exhibited a lower rate of adverse reactions（3.38%）compared to the control group（8.62%）.

The combination of Sanhuangtangshenkang with Dapagliflozin is highly effective and safe for improving renal function，glycemic control and TCM syndromes in patients with early-stage DN characterized by Qi deficiency and blood stasis，demonstrating both enhanced safety and superior efficacy.