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Background The incidence of diabetic kidney disease (DKD) is increasing, which has become a major cause of end-stage renal disease. DKD has an insidious onset, and progresses rapidly since the presence of proteinuria, it is difficult to slow down its progression with conventional therapy especially when renal function is significantly impaired. Therefore, it is urgently necessary to explore an effective treatment for delaying the progression of advanced DKD. The Xiezhuoxiaozheng therapy, proposed by Professor WANG Yaoxian in accordance with the pathogenesis of advanced DKD manifested by turbid poison and mass signs and symptoms (zhengjia) , has proven to be effective in clinical treatment of advanced DKD. Objective To assess the clinical efficacy and safety of Xiezhuoxiaozheng therapy in advanced DKD based on the theory of "latent internal heat causing renal collateral mass". Methods A real-world, prospective cohort study design was used to investigate the clinical efficacy and safety of Xiezhuoxiaozheng therapy for advanced DKD in seven hospitals (Dongzhimen Hospital, Beijing University of Chinese Medicine, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine, Wangjing Hospital of CACMS, Xiyuan Hospital of CACMS, Beijing Hospital of Integrated Traditional Chinese and Western Medicine, and Beijing Fangshan District Hospital of Traditional Chinese Medicine) from 2016 to 2020. Patients with DKD who met the inclusion criteria were recruited and divided into a control group (basic western medical treatment) and a test group (basic western medical treatment plus Xiezhuoxiaozheng therapy) taking the method of Xiezhuoxiaozheng and eliminating symptoms as the exposure factor, and received 24-week interventions. At baseline, and the end of 4, 12, and 24 weeks of interventions, serum creatinine (Scr) , blood urea nitrogen (BUN) , 24-hour urine protein, and total cholesterol (TC) , estimated glomerular filtration rate (eGFR) were measured, TCM symptom score was assessed. HbA1c was measured at baseline, and the end of 12, and 24 weeks of interventions. Adverse events were recorded during treatment, and safety was evaluated. Results A total of 59 cases completed the study, including 36 in the test group and 23 in the control group. The intervention duration had significant main effect on eGFR, Scr, and BUN levels in both groups (P