Objective: To investigate the efficacy of Dabuyin Wan (Concentrated Pills) in the treatment of prepubertal gynecomastia in boys and to analyze its impact on sex hormone levels. Methods: A total of 100 boys with gynecomastia diagnosed and treated in our hospital from July 2022 to February 2025 were selected and randomly divided into two groups using a random number table, with 50 cases in each group. The control group received non-pharmacological treatment, while the observation group was treated with Dabuyin Wan (Concentrated Pills). Both groups continued treatment for 6 months. Clinical efficacy, TCM syndrome scores, sex hormone levels [estradiol (E2), luteinizing hormone (LH), testosterone (T), prolactin (PRL)], and adverse reactions were compared between the two groups. Results: The total clinical effective rate in the observation group was higher than that in the control group (χ² = 5.316, P < 0.05). After treatment, the TCM syndrome score in the observation group was lower than that in the control group (t = 15.513, P < 0.05). After treatment, E2, LH, and PRL levels in the observation group were lower than those in the control group, while the T level in the observation group was higher than that in the control group (t = 5.819, 11.000, 7.275, 9.524, respectively; P < 0.05 for all). There was no significant difference in the incidence of adverse reactions between the two groups. Conclusion: The use of Dabuyin Wan (Concentrated Pills) for prepubertal gynecomastia in boys can improve clinical outcomes, alleviate clinical symptoms, modulate sex hormone levels, and demonstrate a favorable safety profile.