Study to evaluate the effect of Tangshen Fang combined with guideline-directed medical treatment on the quality of life and clinical outcomes in patients with diabetic nephropathy: A clinical trial on constructing a novel paradigm of integrated traditional Chinese and Western medicine in the treatment of diabetic nephropathy

Abstract

Background

Diabetic kidney disease (DKD) is one of the most common microvascular complications of diabetes mellitus and has become the primary cause of end-stage renal disease in China. In patients with severe renal insufficiency, Western medical treatments often yield unsatisfactory results. Preliminary studies have indicated that the Chinese herbal formula Tangshen Fang improves estimated glomerular filtration rate (eGFR) in patients with DKD.

Methods/design

This is a multicenter, randomized, open-label, controlled clinical trial. DKD patients with eGFR levels between 25 and 75 mL/min (1.73 m²) and urinary albumin-to-creatinine ratio (UACR) ≥ 30 mg/g, or eGFR level between 25 and 60 mL/min (1.73 m²) and UACR <30 mg will be included. A total of 144 participants will be randomly allocated to the treatment group (Tangshen Fang plus standard Western medicine with or without other traditional Chinese medicine [TCM]) and the control group (standard Western medicine with or without other TCM) at a 1:1 ration. The study duration will be 24 weeks and the follow-up period will be extended to 96 weeks. The primary endpoint will be the change in eGFR from baseline to week 24. Secondary endpoints will include changes in UACR, body weight, waist circumference, blood pressure, lipid levels, fasting plasma glucose, glycosylated hemoglobin A₁c (HbA₁c), and improvement in TCM symptoms and quality of life. Adverse events will also be evaluated.

Discussion

This study will provide evidence of the effectiveness and safety of Tangshen Fang in treating patients with DKD. It will also form the clinical pathway and expert consensus on integrating traditional Chinese and Western medicine for DKD and provide clinical evidence for the rational use of hospital preparations of Tangshen Fang.

Trial registration

Chinese Clinical Trials Registry, ChiCTR2300069269. Registered March 10, 2023.