Objective To investigate the distribution pattern of dampness and turbidity syndrome in patients with diabetic kidney disease (DKD) and to further evaluate the therapeutic efficacy of Haikun Shenxi capsules combined with conventional Western medicine therapy.

Methods A total of 398 DKD patients who received treatment at our hospital between July 2023 and June 2025 were prospectively enrolled. The study comprised 2 stages. In the first stage, the distribution patterns of TCM syndromes were investigated and patients were divided into a group with dampness and turbidity syndrome (n = 214) and a group without dampness and turbidity syndrome (n = 184). Logistic regression analysis was performed to identify the influencing factors of the dampness and turbidity syndrome. Pearson correlation analysis was performed to assess the correlation between the syndrome score of the dampness and turbidity syndrome and the clinical characteristics in patients with DKD. In the second stage, therapeutic efficacy was evaluated in the 214 patients with the dampness and turbidity syndrome. Propensity score matching (PSM) at a 1∶1 ratio was used to match patients receiving conventional Western medicine therapy alone with those receiving conventional Western medicine therapy combined with Haikun Shenxi capsules. As a result, 82 patients were included in the conventional Western medicine treatment group and the combination treatment group, respectively. Patients in the combination treatment group received Haikun Shenxi capsules in addition to conventional Western medicine therapy for a treatment course of 4 weeks. The primary outcome measures were the renal function indicators before treatment and at the end of treatment. The clinical efficacy, TCM syndrome scores, and adverse reactions were also compared between the 2 groups at the end of treatment.

Results Logistic regression analysis showed that the levels of fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), serum creatinine (Scr), blood urea nitrogen (BUN), and estimated glomerular filtration rate (eGFR) were influencing factors of the dampness and turbidity syndrome (P < 0.05). Pearson correlation analysis showed that the dampness and turbidity syndrome scores of DKD patients increased with the progression in DKD stages. In stage 3 DKD, the dampness and turbidity syndrome was frequently accompanied by Qi deficiency syndrome and Yin deficiency syndrome, while the proportions of patients with Qi deficiency syndrome and Yang deficiency syndrome increased significantly in stages 4 and 5. Renal function indicators, including Scr, BUN, and eGFR, improved after treatment in both groups (P < 0.001), with significantly greater improvement observed in the combination treatment group (P < 0.001). Clinical efficacy and TCM syndrome scores of the combination treatment group were also significantly better than those of the conventional Western medicine treatment group (P < 0.001). There was no statistically significant difference in the incidence of adverse reactions between the 2 groups.

Conclusion Dampness and turbidity syndrome is prevalent among DKD patients, and the proportion of patients with concomitant Qi deficiency syndrome and Yang deficiency syndrome increases as the disease progresses. Haikun Shenxi capsules combined with conventional Western medicine therapy may provide favorable clinical efficacy and improve renal function indicators and TCM symptoms in DKD patients with the dampness and turbidity syndrome.