Research on Innovative Traditional Chinese Medicine Diagnosis and Treatment Technologies for Diabetic Nephropathy Driven by Multi-Omics and Artificial Intelligence

Cooperative units jointly carry out a prospective randomized placebo-controlled parallel double-blind study, relying on a multi-center clinical research platform, and verify through multi-center, prospective, double-blind RCT studies the clinical value of the Jia Jian Yi Shen Xiao Zheng Qu Feng Formula in improving the remission rate of DKD, in order to optimize the treatment strategy for DKD.

Inclusion criteria

• Meets the clinical diagnostic criteria for diabetic nephropathy;
• Aged 18-75 years, any gender;
• eGFR >45 ml/min/1.73m²;
• 24-hour urine protein <2.0 g/day;
• Exhibits Traditional Chinese Medicine patterns of deficiency, stasis, or rheumatic symptoms;
• Willing to participate in the study, able to attend regular follow-ups, and provide informed consent;
• Has maintained a stable basic treatment plan (including hypoglycemic, antihypertensive, and lipid-lowering therapies) for ≥1 month prior to enrollment; during the first 3 months after enrollment, ARB, finerenone, and SGLT2 inhibitor therapies should generally not be adjusted.

Exclusion criteria

• Acute kidney injury or renal function impairment caused by other reasons (recent rapid decline in renal function, or kidney damage caused by drugs, infections, etc.);
• Other primary or secondary kidney diseases (such as systemic lupus erythematosus, polycystic kidney disease, etc.);
• Uncontrolled severe complications (such as severe cardiovascular disease, uncontrolled hypertension, severe infections, etc.);
• Critical organ failure (severe diseases of the heart, liver, or lungs);
• Pregnancy or planned pregnancy (women currently pregnant or planning to become pregnant during the study);
• Drug allergy or clear contraindications (allergic to the study drug or its components);
• Non-cooperative or unable to follow the study protocol (unable or unwilling to comply with study requirements);
• Abnormal coagulation function, or undergoing anticoagulant therapy (such as warfarin, rivaroxaban, etc.) with bleeding risk;
• Currently taking Chinese herbal medicine or patent Chinese medicine with effects of tonifying deficiency, promoting blood circulation, or dispelling wind-dampness.