Tinnitus affects 10%-30% of the population. Recent evidence suggests that tinnitus is associated with spleen deficiency. However, compared with kidney deficiency-related tinnitus, less research has been conducted on the impact of spleen deficiency-related tinnitus. To investigate the clinical efficacy of using Guipi Wan and dietary and lifestyle modification based on traditional Chinese medicine for treatment of patients with spleen and stomach deficiency-related tinnitus. We enrolled 110 patients with spleen and stomach deficiency-related tinnitus who were distributed into treatment (58 cases) and control (52 cases) groups. Tinnitus severity, sleep quality and emotional state were assessed by questionnaires [Tinnitus Evaluation Questionnaire (TEQ); Pittsburgh Sleep Quality Index (PSQI); Depression-Anxiety-Stress Scale-21 (DASS-21)] that were used for analysis in the two groups during the initial and intervention and after. In the treatment group, patients were treated with oral administration of Guipi Wan and consulted for healthy dietary and lifestyle modification. In the control group, patients were only assessed and not treated. At the end of the 6-months, TEQ scores decreased significantly in the treatment group (P = 0.021) but not in the Control group. Significant effects in the treatment group were noted for PSQI total score (P = 0.043) and several PSQI component scores in the treatment group (P < 0.05). After treatment, the DASS-21 scores were significantly reduced in the treatment group (P < 0.05). Guipi Wan combined with dietary and lifestyle modification based on regulating the spleen and stomach can be considered core to the treatment of tinnitus related to spleen and stomach deficiency.