Abstract：Objective To  explore the clinical efficacy and safety of Shugan Huatan Sanjie Recipe in the treatment of thyroid nodules with Qi stagnation phlegm coagulation. Methods Sixty patients of thyroid nodules with Qi stagnation phlegm coagulation were selected and randomly divided into control group and observation group with random number table method, 30 cases in each group. The patients in control group were treated with thyroid hormone inhibitors, and in the observation group were treated with Shugan Huatan Sanjie Recipe.The clinical treatment efficiency, TCM syndrome efficacy,as well as TCM syndrome scores,maximum nodule diameter, the change of TSH before and after treatment of the two groups were compared, and the safety of medicine were analyzed. Results The total effective rate of clinical treatment in the observation group was higher than that in the control group.The TCM syndrome scores after treatment of the two groups were lower than before treatment and the observation group was more obvious. The maximum nodule diameter and TSH level after treatment in the two groups were significantly lower than before treatment, the differences were statistically significant（allP＜0.05）; There was no significant change in liver and kidney function, blood routine and electrocardiogram in the two groups after treatment. Conclusion Shugan Huatan Sanjie Recipeis clinically effective in treating thyroid nodules with Qi stagnation phlegm coagulation, which can reduce the maximum nodule diameter and TSH levels. It is safe and worthy of promotion.