Backgrounds : Hyperlipidemia is a major cause of cardiovascular disease (CVD). Lowering serum cholesterol levels could reduce the risk of CVD. Insamsansa-eum (Renshenshanzha-yin, ISE), composed of Ginseng Radix and Crataegii Fructus, is a new medicine developed to treat hyperlipidemia and CVD. Objectives : In this study, we intended to explore the clinical effects of ISE on patients with hypercholesterolemia, and moreover we also compared its effects according to the pattern identification. Methods : Subjects were administered ISE with the dose of 600 mg three times a day for 4 weeks. Patterns of subjects were identified with diagnostic scoring system for Yin-Yang and the condition of Excess-Deficiency before treatment. Serum lipids were measured at baseline and after 4 weeks of medication. Results : ISE lowered total cholesterol(TC), triglyceride(TG), total lipid(TL), phospholipid(PL) and low density lipoprotein cholesterol(LDL) significantly. Compared with the data of our previous study, it was less effective than Atorvastatin but showed equal lipids-lowering effect to Chunghyul-dan (Qingxue-dan, CHD). In Yang pattern group, ISE was less effective in lowering TG and LDL than it was in not-Yang-not-Yinpattern group. On safety assessment, there was no adverse effect, hepatic or renal toxicity. Conclusions : We suggest that ISE is a safe and useful herbal medicine for hypercholesterolemia, and moreover it could be more useful when it is used for patients with not Yang pattern.