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Background and aims Long-term nucleos(t)ide analogues (NAs) treatment can reverse liver fibrosis in chronic hepatitis B (CH, but its effect on fibrosis regression remains limited. Biejia-Ruangan (BR) has been approved in China as an anti-fibrotic traditional Chinese medicine drug in patients with chronic liver diseases. A multicenter randomized controlled trial aims to evaluate the effect of BR on fibrosis regression in CHB patients treated with NAs. Methods CHB patients with histologically confirmed advanced fibrosis or cirrhosis we