To evaluate Xiaopi Granule in improving hyperplasia of mammary glands with phlegm and blood stasis and Chong-ren dysfunction syndrome. Methods：A randomized，double-blind，double-dummy，multi-center clinical research was conducted，including eight hospitals，478 cases of hyperplasia of mammary glands with phlegm and blood stasis and Chong and Ren dysfunction Syndrome. The 359 cases in experimental group received Xiaopi Granule and placebo of Ruhesanjie tablet. And 119 cases in control group took Ruheshanjie tablets and placebo of Xiaopi Granule. One menstrual cycle was a course of treatment，and three menstrual cycles were continuous observed. Patients that were clinically recovered were followed up for one month. Results：Generally speaking，Xiaopi Granule were much better than Ruheshanjie tablets in treating hyperplasia of mammary glands with phlegm and blood stasis and Chong and Ren dysfunction Syndrome，especially in improving breast pain，tenderness，breast texture，and Chinese medicine symptoms and syndromes. Conclusion：Xiaopi Granule has good clinical efficacy and safety in treating hyperplasia of mammary glands with phlegm and blood stasis and Chong-ren dysfunction syndrome.