Objective: To observe the clinical efficacy of “Xiaoying Mixture” in treating benign thyroid nodules  Methods: One hundred cases with benign thyroid nodules were randomized into treatment group and control group, with 50 cases in each group. Control group was treated with “Neixiao Luoli Pills” orally, and treatment group was treated with “Xiaoying Mixture” orally, with the course of 3 months. The clinical efficacy, maximum diameters of thyroid nodules and TCM symptom scores were observed  Results: ① The total effective rate was 80.00% in the treatment group and 60.00% in the control group, with a difference between the two groups (P<0.05). ② In both groups, there were significant differences in the maximum diameters of thyroid nodules between before and after treatment (P＜0.05); with significant differences between the two groups(P＜0.05). ③ In both groups, there were significant differences in TCM symptom scores between before and after treatment (P＜0.05); with significant difference value between the two groups (P＜0.05)  Conclusion: “Xiaoying Mixture” is effective to shrink the thyroid nodules and improve clinical symptoms in patients with benign thyroid nodules.