A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease

We are conducting this clinical trial to find out whether Guominkang-a traditional Chinese herbal formula-is safe and effective for people with diabetic kidney disease (DKD). DKD is a common complication of diabetes, affecting 20% to 40% of patients. If not well controlled, it can lead to chronic kidney disease or even kidney failure. Current treatments mainly focus on controlling blood sugar and blood pressure, but few therapies directly target immune inflammation, which plays a key role in DKD progression. In earlier animal studies, Guominkang reduced urine protein and blood sugar in mice with DKD and appeared to work by balancing both metabolism and immune-inflammatory responses. This pilot study will enroll 18 adults aged 18-70 years with mild-to-moderate kidney damage (CKD stages G1-G3) due to DKD. Participants will be divided into three groups (6 per group): Observation group: receives standard care only (medications to control blood sugar, blood pressure, and lipids); Standard-dose group: standard care + 1 dose of Guominkang per day; Double-dose group: standard care + 2 doses of Guominkang per day. The treatment lasts 12 weeks, followed by a 4-week follow-up after stopping the study drug. During the study, you will need to: Take your assigned medication (or continue standard treatment) as directed; Visit the clinic at weeks 2, 4, 8, 12, and 4 weeks after stopping treatment; Provide blood and urine samples for testing (e.g., urine protein, blood sugar, cholesterol, kidney function). We hope to answer two main questions: Can Guominkang reduce urine protein in patients with DKD? Is Guominkang safe-what side effects might occur?

Inclusion Criteria: * Clinically diagnosed DKD; * Age 18-70 years; * eGFR ≥30 mL/min/1.73 m² (CKD-EPI equation); * UACR ≥200 mg/g on two or more occasions within 3 months; * Stable treatment with ACEI/ARB for ≥3 months; * If taking SGLT2 inhibitors or non-steroidal MRAs, stable use for ≥4 weeks and continued throughout the study; * If taking other herbal medicines for kidney disease (e.g., Huangkui Capsule), must continue stable use; * Willingness to participate and signed informed consent. Exclusion Criteria: * eGFR \