Huangjia Ruangan granules with entecavir for fibrosis regression in Chroinc Hepatitis B: A multicenter, randomized, double-blind, phase II trial

BACKGROUND: Huangjia Ruangan Granules (HRG) has shown promising therapeutic effects in treating hepatic fibrosis in China. This study aimed to assess its specific efficacy. METHODS: This 48-week phase II study was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 14 centers in China (No. ChiCTR2400086796). patients with chronic hepatitis B (CHB) and an Ishak fibrosis score between 2 to 5 were eligible for inclusion. Patients were randomly assigned to three groups (1:1:1 ratio): ETV (0.5 mg/day) + HRG-10g (10g/day, once daily), ETV (0.5 mg/day) + HRG-20g (10 g, twice daily), and ETV (0.5 mg/day) + placebo. The primary outcome was the change in fibrosis stage according to the Ishak scale. Safety assessments were conducted throughout the trial. RESULTS: A total of 240 participants were randomly allocated to three treatment groups: ETV+HRG-10g (n=80), ETV+HRG-20g (n=79), or ETV+placebo (n=80). After 48 weeks, the ETV+HRG-20g group showed a significantly higher fibrosis regression rate (≥1 stage improvement in histopathology) was in the compared to both the ETV+HRG-10g group (67.09 % vs. 36.25 %; 95 % CI, 15.81-45.6) and the ETV+placebo group (67.09 % vs. 26.25 %; difference, 40.69 %; 95 % CI, 26.55-54.83). CONCLUSIONS: Combining a 20g dose of the TCM formula HRG with ETV significantly enhances liver fibrosis regression in CHB patients.