Objectives : To demonstrate the importance of syndrome differentiation in clinical research of herb medication, through the comparative study on efficacy and safety of herb medication according to cold-heat tendency of OA knee patients. Methods : During December 2010 to July 2011, 138 knee OA patients were randomly assigned to WIN-34B 600mg(300mg, b.i.d.), 1,200mg(600mg, b.i.d.) and placebo b.i.d. for 8 weeks. Patient were re-classified into cold-heat tendency group according to cold-heat questionnaires. To investigate efficacy and safety, we assessed the 100mm pain VAS at baseline and 8 weeks later, and we monitored adverse event of patients during treatment period. Results : 1. Efficacy study : In WIN-34B 1,200mg group, VAS mean changes of heat tendency group showed slightly increase than those of cold tendency, but no significant difference within two groups. In heat tendency group, WIN-34B 1,200mg group showed a significant decrease of VAS compared to placebo group. but there were no significant difference in cold tendency group. 2. Safety study; In WIN-34B 600mg group, incidence of adverse events of cold tendency group was higher than those of heat tendency, but not in WIN-34B 1,200mg group. Conclusions : This study suggests that WIN-34B tend to have more efficacy in heat tendency-knee OA patients and WIN-34B is safe drug relatively, regardless of cold-heat tendency. In further clinical research on efficacy and safety of WIN-34B, stratification using syndrome differentiation is required.