To assess the efficacy and safety of the method for soothing the liver and strengthening the spleen in patients with FD of spleen-deficiency and qi-stagnation syndrome. The major concerns of patients were investigated by patient-reported outcome. Methods: A randomized, double-blind, placebo-controlled trial was performed with patients from five centers. Patients with FD of spleen-deficiency and qi-stagnation syndrome (n＝160) were randomly assigned to groups given CHM spleen-strengthening and liver-qi regulating decoction or placebo in a 2∶1 ratio. Herbal medicine or placebo granules were dissolved in 300 ml of boiled water cooled to 70 ℃. Patients in both groups were administered 150 ml twice daily. The trial included a 4-week treatment period and a 4-week follow-up period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4 and 8. The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment. Results: Compared with patients in the placebo group, patients in the CHM group showed significant improvement according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients (P<0.01 or P<0.05). They also showed an improvement in the number of radiopaque barium markers emptied from the stomach (P<0.05). During the clinical trial, there is no adverse event related to the herbal medicine. Conclusion: The method for soothing the liver and strengthening the spleen appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome and is safe.