Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025
Efficacy and safety of Chaihuang Tongluo oral liquid in patients with chronic kidney disease: A single-center, randomized, open-label, controlled trial.
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Congcong Zeng, Liting Zhu, Hongyang Qiao, Meixia Fan, Feng Wang, Tingting Wei, Zhengzhong Yuan, Jinguo Cheng
Аннотация
BACKGROUND: Slowing the decline of estimated glomerular filtration rate (eGFR) remains a central therapeutic goal in early-stage chronic kidney disease (CKD). Chaihuang Tongluo Oral Liquid (CHTL), a Traditional Chinese Medicine formulation, has demonstrated effects in preclinical studies. However, its impact on clinically relevant renal outcomes in patients has yet to be rigorously evaluated.
AIMS: This trial aimed to evaluate the efficacy and safety of CHTL as an adjunctive therapy for early-stage CKD.
STUDY DESIGN AND METHODS: In this prospective, randomized, assessor-blind, controlled trial, 114 adults with CKD stages 1-3 were assigned to receive either standard care plus CHTL (25 ml, twice daily) or standard care alone for 48 weeks. The primary outcome was the slope of eGFR change. Secondary outcomes included percentage changes in eGFR, urinary albumin-to-creatinine ratio (UACR), serum biomarkers (TGF-β1, VEGF, FGF-21), renal tissue stiffness (Yang modulus), and TCM syndrome scores.
RESULTS: The CHTL group exhibited a significantly slower decline in eGFR (between-group difference in slope: 2.41 ml/min/1.73 m², p < 0.001), with a median eGFR change of 0.00% (IQR -2.64 to 4.58) versus -4.95% (IQR -14.40 to 2.10) in controls. UACR decreased by 25.1% with CHTL but increased by 10.2% in controls (p = 0.015). FGF-21 levels increased by 3.35% with CHTL versus a 4.96% decrease in controls (p = 0.04). Renal tissue stiffness improved (-2.25% vs. +5.88%, p = 0.002), and TCM symptom scores improved by 60.1% versus 23.8% (p < 0.001). No severe adverse events occurred.
CONCLUSION: CHTL significantly attenuated eGFR decline, reduced albuminuria, increased FGF-21 levels, improved renal tissue elasticity, and alleviated TCM symptoms in patients with early CKD, demonstrating safety and multi-dimensional efficacy as a complementary therapy.
CLINICAL TRIAL REGISTRATION NUMBER: ChiCTR2200062501 (Chinese Clinical Trial Registry).
AIMS: This trial aimed to evaluate the efficacy and safety of CHTL as an adjunctive therapy for early-stage CKD.
STUDY DESIGN AND METHODS: In this prospective, randomized, assessor-blind, controlled trial, 114 adults with CKD stages 1-3 were assigned to receive either standard care plus CHTL (25 ml, twice daily) or standard care alone for 48 weeks. The primary outcome was the slope of eGFR change. Secondary outcomes included percentage changes in eGFR, urinary albumin-to-creatinine ratio (UACR), serum biomarkers (TGF-β1, VEGF, FGF-21), renal tissue stiffness (Yang modulus), and TCM syndrome scores.
RESULTS: The CHTL group exhibited a significantly slower decline in eGFR (between-group difference in slope: 2.41 ml/min/1.73 m², p < 0.001), with a median eGFR change of 0.00% (IQR -2.64 to 4.58) versus -4.95% (IQR -14.40 to 2.10) in controls. UACR decreased by 25.1% with CHTL but increased by 10.2% in controls (p = 0.015). FGF-21 levels increased by 3.35% with CHTL versus a 4.96% decrease in controls (p = 0.04). Renal tissue stiffness improved (-2.25% vs. +5.88%, p = 0.002), and TCM symptom scores improved by 60.1% versus 23.8% (p < 0.001). No severe adverse events occurred.
CONCLUSION: CHTL significantly attenuated eGFR decline, reduced albuminuria, increased FGF-21 levels, improved renal tissue elasticity, and alleviated TCM symptoms in patients with early CKD, demonstrating safety and multi-dimensional efficacy as a complementary therapy.
CLINICAL TRIAL REGISTRATION NUMBER: ChiCTR2200062501 (Chinese Clinical Trial Registry).