This double-blind, randomised, and multicentered study aimed to evaluate the
safety and effect of a G. lucidum extraction, Ganopoly,
in chronic hepatitis B. Ninety patients with chronic hepatitis B, hepatitis В viral (HBV) DNA positivity, and aminotransferase elevation were included in this multicenter prospective randomized Phase I/II study. Patients were randomized to be given Ganopoly (n = 60) or placebo (n = 30) for 12 weeks, then followed up for 13 weeks.