OBJECTIVE： To evaluate the efficacy and safety of Honghua xiaoyao tables in the treatment of delayed menstrual cycle of liver-depression and qi-blood stagnation. METHODS： In a randomized， double blind， double-dummy， positive drug and placebo parallel controlled， multicenter clinical trial， 144 subjects were enrolled and randomly divided into trial group （72 cases）， positive control group （36 cases） and placebo group （36 cases）. Trial group was treated with Honghua xiaoyao tables， and positive control group was given Nvjin tables. Treatment course lasted for 8 weeks， and they stopped taking drugs during menstrual period. RESULTS： After treatment， main therapeutic efficacy （delayed menstrual cycle） of trial group was better than that of positive control group， without statistical significance （P＞0.05）； that of trial group was significantly better than that of placebo group， with statistical significance （P＜0.05）. In the field of secondary therapeutic efficacy [TCM syndrome efficacy， therapeutic efficacy of each TCM syndrome （excpet menstrual colour and property， irritable）， etc]， trial group was better than positive group and placebo group， with statistical significance （P＜0.05）. No ADR was found in 3 groups during treatment. CONCLUSIONS： Honghua xiaoyao tables has been proved to be safe and effective in the treatment of delayed menstrual cycle of liver-depression and qi-blood stagnation.