Objective: To study the efficacy and safety of Shixin buccal tablets on the treatment of recurrent aphthae with syndrome of flaring up of the stomach-fire. Methods: A randomized, double-blind, placebo controlled, parallel-group, and multicenter study with single simulation was conducted. The patients in experimental group and the control group were given Shixin buccal tablets and placebo respectively for 5 days. The clinical outcomes consisted of the primary outcome (onset time of pain relief) and the secondary outcomes (rate of ulcer healing, days for ulcer healing, numbers of ulcers, pain sc...