Xiaojin Pill/Neixiao Luoli Pill for the Treatment of Thyroid Nodules

This study is designed to evaluate the clinical value of adding traditional Chinese medicine to standard lifestyle intervention for the management of benign or low-risk thyroid nodules. The trial adopts a randomized, parallel-group design conducted across multiple clinical centers. After screening and baseline assessments, eligible participants are allocated to one of three management strategies: lifestyle intervention alone or lifestyle intervention combined with one of two commonly used traditional Chinese patent medicines. The study is conducted in an open-label manner, reflecting real-world clinical practice. All participants receive standardized lifestyle guidance throughout the study period. Participants assigned to the intervention groups additionally receive oral herbal medication for a fixed treatment duration. Clinical assessments are performed at predefined time points to monitor structural changes of thyroid nodules, functional status of the thyroid gland, symptom evolution, and treatment safety. Thyroid ultrasound examinations are performed using standardized measurement procedures to ensure consistency across centers. Safety is continuously monitored through clinical evaluation and routine laboratory testing during the treatment and follow-up periods. The results of this study are expected to provide evidence regarding the role of traditional Chinese medicine as an adjunct to lifestyle management in patients with thyroid nodules under active surveillance.