Objective: The aim of this study is to investigate the anti-viral effects of a Chinese Herbal Formula (invigorating the kidney and the spleen gelatin capsule) in treating chronic hepatitis B Virus carriers. Method: This was a randomized

double-blind

placebo-controlled study. 90 patients enrolled in the study who were satisfied with the following criteria: presence of hepatitis B surface antigen and hepatitis B e antigen

HBV DNA level greater than 7 log10 copies/mL

and normal alanine aminotransferase level (30~40 U·mL-1 for male

and 20~40 U·mL-1 for female). They were randomly divided into trial group (n=60) and control group (n=30). During the trial period

patients in both trial group and control group received medication invigorating the kidney and the spleen gelatin capsule and a placebo for 48 weeks respectively

4 capsules per time

3 times per day. The serum HBV DNA level

serum markers of HBV(HBsAg

HBsAb

HbeAg

HBeAb

HbcAb) and serum biochemistry of liver functions(ALT

AST

GGT

TBil) were measured at the before and 48th week of the treatment. And the indexes of safety

such as blood analysis

stool analysis

urinalysis

renal functions and electrocardiogram were also detected. Result: After treatments

the median decrease in serum HBV DNA levels was 3.4 log10 copies/mL in the trial group and 0.1 log10 copies/mL in the control group (P＜0.01). Serum HBV DNA ＜3log10 copies/mL was observed in 13 of the 60 subjects (21.7%) in the trial group and 1 of the 30 subjects (3.3%) in the placebo group (P＜0.01). The proportion of patients with HBeAg loss was 20% (12/60) and 3.3% (1/30) respectively in the trial group and control group (P＜0.01). The ratio of HBeAg seroconversion to anti-HBe was 15% (9/60) in the trial group and 0% (0/30) in the control group (P＜0.05). Conclusion : Invigorating the kidney and the spleen gelatin capsule is effective in inhibiting the copy of hepatitis B virus and increase the ratio of HBeAg seroconversion

which can be used to treat Chronic Hepatitis B Virus carriers.