Objective: To evaluate the efficacy and safety of Chinese medicine (CM) in treating infantile cytomegalovirus hepatitis (ICH). Methods: A total of 100 infant ICH patients were randomly assigned to two groups, 60 in the treatment group and 40 in the control group. Ganciclovir was administered to all patients via intravenous dripping at dose of 5 mg/kg every 12 h for 2 weeks, followed by 5 mg/kg once a day for 5 days every week; the whole treatment course lasted 8 weeks. Besides, the patients in the treatment group were treated with CM of Qinggan Lidan Decoction (V-filI)IRA, OLD) during icteric stage, and Yigan Jiangmei Decoction (A)1fil*-44A, YJD) in non-icteric hyper-aminotransferase stage by oral medication, while for those in the control group, glucurolactone 50 mg was given three times per day. The efficacy of treatment was evaluated at the ends of 2nd, 4th and 8th weeks, respectively. And a follow-up study was carried out for 6-24 months. Results: The total effective rate was 95.0% (57/60) in the treatment group and 77.5% (31/40) in the control group; the overall curative effect in the former was superior to that in the later, showing a significant difference (P=0.021). Cholestasis and liver function were improved in both groups, and the effect of reducing serum bilirubin level in the treatment group was more rapid and extensive than that in the control group, which could reduce the post-hepatitis cirrhotic risk caused by long-term cholestasis and liver cell damage. Conclusion: The therapeutic efficacy of integrated CM and Western medical drug therapy, by using OLD during icteric stage and YJD in nonicteric hyper-aminotransferase stage, was significantly higher than that of routine Western medical treatment alone; it was an ideal project for the treatment of infantile cytomegalovirus hepatitis.