Efficacy and Safety of Chaihuang Tongluo Oral Liquid in Patients with Chronic Kidney Disease: A Single-Center, Randomized, Open-Label, Controlled Trial

BackgroundChronic kidney disease (CKD) is a progressive condition with limited therapeutic options. Traditional Chinese Medicine (TCM) may provide adjunctive benefits by targeting multiple disease mechanisms. ChaiHuang Tongluo Oral Liquid (CHTL), a standardized Traditional Chinese Medicine (TCM) formulation, has demonstrated anti-fibrotic potential in preclinical studies.AimsThis trial aimed to evaluate the efficacy and safety of CHTL as an adjunctive therapy for early-stage CKD.Study design and MethodsIn this prospective, randomized, assessor-blind, controlled trial, 114 adults (aged 18–80 years) with CKD stages 1–3 (eGFR ≥30 mL/min/1.73 m2) were randomized 1:1 to receive either 48-week add-on CHTL or standard care alone. The primary outcome was the slope of eGFR change. Secondary outcomes included percentage changes from baseline to week 48 in eGFR, urinary albumin-to-creatinine ratio (UACR), serum biomarkers (TGF-β1, VEGF, FGF-21), renal tissue stiffness (Yang modulus), and TCM syndrome scores, alongside safety assessments.ResultsThe CHTL group showed a significantly slower eGFR decline (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.ConclusionCHTL significantly attenuated eGFR decline, reduced albuminuria, increased FGF-21 levels, improved renal tissue elasticity, and alleviated TCM symptoms in early CKD patients, demonstrating safety and multi-dimensional efficacy as a complementary therapy.Clinical Trial Registration NumberChiCTR2200062501 (Chinese Clinical Trial Registry)