Objective To study the optimal effective dosage of Shugan Granule（ 舒肝颗粒） in relieving symptoms of women with breast hyperplasia. Methods A randomized

double-blind

placebo-controlled method was used to enroll 240 patients with hyperplasia of mammary glands with liver qi stagnation syndrome in 5 centers. Subjects were randomly divided into a conventional dose group（ 90 cases）

a high-dose group（ 90 cases）

and a placebo group（ 60 cases）

and they were given 3 menstrual cycles treatment of Shugan Granule conventional dose（ equivalent to 5 g of the original medicine）

high dose（ equivalent to 10 g of the original medicine）

and the placebo treatment respectively. The post-treatment breast pain numeric rating scales（ NRS） of the most painful day and the number of days of significant breast pain（ days with NRS ≥ 3）

the change in the size of the target breast mass and the disappearance rate of individual symptoms after treatment were observed. Results After 3 menstrual cycles treatment

the Shugan Granule high dose and conventional dose treatment group were all better than placebo group in the reduction from baseline the most painful NRS score

the number of days with NRS≥ 3

mass size of target breast palpation and the symptoms disappearance rate（ P < 0. 05 or P < 0. 0125）

while there was no statistical differences between the high dose and conventional dose group（ P > 0. 05 or P > 0. 0125）. Conclusion Conventional dose of Shugan Granule is 5 g per time

twice a day as the optimal effective dose in relieving symptoms of women with breast hyperplasia of liver depression and qi stagnation syndrome.