Abstract：Objective：To observe the clinical efficacy of Huoxue Xiaoying Soft Extract in treating thyroid nodules of phlegm coagulation and blood stasis type. Methods： A total of 100 patients with thyroid nodules of phlegm coagulation and blood stasis type who attended the outpatient clinic of the Department of Endocrinology， Shenzhen Bao'an Traditional Chinese Medicine Hospital from October 2023 to May 2025 were enrolled in this study. Using a random number table method，the participants were divided into a treatment group and a control group at a 1∶1 ratio， with 50 cases in each group. The control group received conventional lifestyle management，while the treatment group received oral Huoxue Xiaoying Soft Extract in addition to the lifestyle management. Both groups received continuous intervention for 12 weeks. The clinical efficacy and safety were compared between the two groups，as well as changes in traditional Chinese medicine syndrome scores， maximum diameter of thyroid nodules， and thyroid function [thyroidstimulating hormone （TSH），free thyroxine （FT4），free triiodothyronine （FT3）] before and after treatment. Results： After treatment，the total effective rate was 84.00% （42/50） in the treatment group and 16.00% （8/50） in the control group，with a statistically significant difference between the two groups （P＜0.05）. After treatment，traditional Chinese medicine syndrome scores in the treatment group decreased compared to before treatment （P＜0.05），and the scores in the treatment group were lower than those in the control group （P＜0.05）； there was no statistically significant difference in traditional Chinese medicine syndrome scores in the control group before and after treatment （P＞0.05）. After treatment， the maximum diameter of thyroid nodules in the treatment group decreased compared to before treatment （P＜0.05）， and the maximum nodule diameter in the treatment group was smaller than that in the control group （P＜0.05）； there was no statistically significant difference in the maximum diameter of thyroid nodules in the control group before and after treatment （P＞0.05）. After treatment， the improvement rate of thyroid nodules was 62.00%（ 31/50） in the treatment group and 4.00%（ 2/50） in the control group，with a statistically significant difference between the two groups （P＜0.05）. Before and after treatment， there were no statistically significant differences in serum levels of TSH，FT3，and FT4 between the two groups （P＞0.05）. During the treatment period，no significant adverse reactions were observed in either group. Conclusion： Huoxue Xiaoying Soft Extract can effectively improve traditional Chinese medicine syndrome， alleviate clinical symptoms， and reduce the maximum diameter of thyroid nodules with good safety in treating thyroid nodules.