Heilongjiang Kuihua Pharmaceutical Co. Ltd.

1. Evaluate the effectiveness of liver protection tablets in treating acute drug-induced liver injury using the decrease value, decrease rate, recovery rate, and recovery time of serum ALT and AST relative to the baseline. 2. Observe the safety of liver protection tablets in clinical application.

To explore the preliminary results of the effectiveness of different doses of Shuangshen Yigan Drop Pills compared with interferon α-2b in the treatment of chronic hepatitis B with qi and yin deficiency and damp-heat accumulation in inhibiting hepatitis B virus replication, and to evaluate the improvement of liver function, clinical symptoms (TCM syndromes) and safety and tolerability.

To explore the preliminary results of the effectiveness of Shuangshen Hepatitis B Drop Pills in inhibiting the replication of hepatitis B virus in comparison with the positive drugs lamivudine tablets and Huju Hepatitis B Capsules in the treatment of chronic hepatitis B with qi and yin deficiency and damp-heat accumulation syndrome, and to evaluate the improvement of liver function and clinical symptoms (TCM syndromes) as well as safety and tolerability.