A randomized, double-blind, placebo-controlled trial of Wenshenyang decoction for the improvement of renal function and kidney-yang deficiency syndrome in patients with CKD

作者：Ge Jin, Wenge Li, Luying Sun, Baokui Wang, Lanying Liu, Chao Dong, Tingting Jiao, Qi Wu, Yunhua Liu, Xinjiang Zhang, Shuyue Wang, Sitong Wang, Kaidong Zhou, Yanmo Cai, Xin Zhou, Xinxue Zhang, Kun Liu, Zongjiang Zhao · 发表于：Journal of Ethnopharmacology · 年份：2025 · DOI：10.1016/j.jep.2025.119575 · 被引用次数：10 · 研究领域：Traditional Chinese Medicine Studies、Chronic Kidney Disease and Diabetes、Renal Diseases and Glomerulopathies

ETHNOPHARMACOLOGICAL RELEVANCE: Chronic kidney disease (CKD) poses an increasing challenge to the middle-aged and elderly population. Wenshenyang decoction (WSY), an herbal formula from China, has been shown to have a considerable effect on the recovery of the renal function in a real-world study. However, no randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety yet. AIM OF THE STUDY: This study aimed to investigate the efficacy, advantages, limitations, and safety, and provide insights into methods and strategies for utilizing WSY in CKD management. MATERIALS AND METHODS: Participants were recruited from six tertiary hospitals in Beijing, China. Eligible participants were randomly assigned to receive either WSY and conventional Western medicine or placebo and conventional Western medicine in a 1:1 ratio. The treatment and follow-up cycles each lasted 90 days, with a total of six follow-up visits. The primary outcome measures were the change in 24-h urine protein excretion (24h UPRO) and serum creatinine (SCR) from baseline at Visit 3 (90 days after the treatment) and Visit 5 (90 days after the follow-up). The secondary outcome measures were the improvement in symptoms and other renal function indicators. Additionally, we explored the correlation between the effect of WSY treatment and CKD type and stage through subgroup analysis. Finally, the safety of this decoction was assessed. RESULTS: In total, 257 participants were...