Anti-hepatofibrotic effects of CGX, a standardized herbal formula: A multicenter randomized clinical trial

Background: Chunggan extract (CGX) is an herbal formula used for the treatment of chronic liver disease in traditional Korean medicine. Many preclinical studies have suggested its therapeutic or preventive effects on liver fibrosis. To evaluate the efficacy and safety of CGX, we conducted a randomized controlled clinical trial of CGX in patients with liver fibrosis diagnosed by Fibroscan. Methods: We enrolled 67 subjects at two hospitals with chronic liver disorders with a 5.5 ≤ liver stiffness measurement (LSM) score ≤ 16 kPa. Subjects were randomly assigned at a 1:1:1 ratio with stratification (with/without concomitant use of antivirals) and orally administered CGX (1 g or 2 g) or placebo twice daily for 24 weeks. The end point was the change in instantaneous elasticity of the liver assessed by Fibroscan before and after treatment. Results: LSM scores were significantly decreased in both the CGX1 g (2.5 ± 1.7 kPa, p < 0.01) and CGX2 g (1.9 ± 2.0 kPa, p < 0.05) groups compared to the placebo (0.6 ± 1.6 kPa) group. The change was also significant in 35 subjects without concomitant use of antiviral agents in the CGX1 g group (placebo 0.1 ± 1.4 kPa vs. 2.7 ± 1.6 kPa, p < 0.01) but not in those with concomitant antiviral use (p > 0.05). No notable adverse events were present. Conclusion: CGX appeared to have a pharmacological effect against liver fibrosis. Further studies to confirm the results are needed in the future using a larger sample size.