Objective To evaluate the effect and safety of Qinggan Lishi Decoction（decoction for clearing heat and dissolving damp） on chronic hepatitis B with liver and gallbladder damp-heat syndrome in TCM through a randomized controlled trial of small-sized samples.Methods Seventy-five subjects met the designed criteria were randomized into a treatment group and a control group.The treatment group

34 cases

was administered Chinese medicine Qinggan Lishi Decoction and Lamivudine tablets

while the control group

41 cases

was administered Compound Glycyrrhizin tablets and Lamivudine tablets.Both groups were treated for 4 weeks.Changes in visual analogue scores（VAS） of independent symptoms and general symptomatic experience

level of alanine aminotransferase（ALT）

viral markers and quantitative value of HBV DNA of the two groups were observed

and the adverse events were monitored in the whole process of trial.Results After treatment

the VAS of independent symptoms and general symptomatic experience and level of ALT were decreased in both groups.The VAS of general symptomatic experience of the treatment group in the 2nd

3rd

and 4th week was significantly lower than that of the control group（P<0.05 or P<0.01）

and the level of ALT in the 3rd week was significantly lower than that of the control group（P<0.05）.Compared with before treatment

in the 12th week of continuous administration of Lamivudine tablets

the differential value of HBV DNA quantity of the experimental group was significantly higher than that of the control group（P<0.05）.No severe adverse events occurred during the whole trial.Conclusion Qinggan Lishi Decoction is possibly beneficial to hepatic symptoms

virus load

and liver function of those patients with chronic hepatitis B in TCM syndrome of liver and gallbladder damp-heat.