A clinical trial led by researchers at Guang'anmen Hospital of the China Academy of Chinese Medical Sciences, along with several traditional Chinese medicine hospitals across China, has evaluated a traditional Chinese herbal formula for treating diabetic kidney disease with macroalbuminuria. The results were published on November 14, 2025, in Precision Clinical Medicine (DOI: 10.1093/pcmedi/pbaf031).
Diabetic kidney disease is a growing complication among people with diabetes and remains the main cause of end-stage renal disease. The condition is characterized by persistent proteinuria and a steady decline in kidney filtration capacity. Standard treatments such as angiotensin-converting enzyme inhibitors and angiotensin receptor blockers can slow this decline but rarely lead to sustained improvement. Side effects from these drugs may also limit their long-term use. There is increasing evidence that chronic inflammation contributes significantly to kidney fibrosis and loss of function in diabetes.
The 24-week multicenter, randomized, double-blind trial enrolled 120 patients and compared the herbal therapy to irbesartan, an angiotensin receptor blocker. Researchers assessed outcomes related to kidney function, safety, and symptom improvement. They also conducted mechanistic studies using proteomics, single-cell transcriptomics, and animal models to investigate how the therapies affected inflammation-related pathways.
Both groups showed similar reductions in 24-hour urinary protein levels—a key marker of kidney damage. However, patients treated with the herbal formulation had better preservation of kidney function: their estimated glomerular filtration rate increased during treatment while it declined in those receiving irbesartan; serum creatinine levels decreased rather than increased in the herbal group. Bayesian statistical analysis indicated a high probability that the herbal therapy provided real benefits for renal health.
To explore why these differences occurred, researchers used Olink inflammation proteomic profiling and found significant reductions in circulating inflammatory mediators like CX3CL1 and MCP-1 after treatment with the herbal formula. Single-nucleus RNA sequencing of diabetic mouse kidneys showed that these molecules are mainly produced by endothelial, mesangial, and tubular cells—key contributors to inflammation and fibrosis in the kidneys. The treatment reduced expression of these molecules in specific cell types.
Animal experiments supported these findings: mice given the herbal therapy had improved biochemical markers for renal health and less structural damage such as fibrosis and mesangial expansion.
"The most striking aspect of this study is the improvement in kidney function, not just stabilization," said one of the corresponding investigators. "Many existing therapies slow decline, but few demonstrate an actual increase in filtration capacity. By integrating clinical trials with molecular and single-cell analyses, we were able to link these functional benefits to specific inflammatory pathways. This systems-level approach strengthens confidence that the observed effects are biologically meaningful and not simply statistical variation."
If further confirmed by larger or longer studies, these results could provide new options for patients who cannot tolerate standard medications or who remain at high risk despite current treatments. The research highlights inflammation as a promising therapeutic target for diabetic kidney disease and suggests that multi-component therapies may have synergistic effects on complex disease processes. The study also demonstrates how combining traditional medicine with modern clinical research methods can help identify new ways to preserve kidney function for people living with diabetes.
