Abstract: Abstract： Objective This study aims to determine the effects of application of berberine gelatin on the treatment of minor RAU (MiRAU).Methods A randomized, double-blind, placebo-controlled, clinical trial was performed. The gelatin containing berberine(5 mg/g) or placebo only was applied 4 times per day for 5 days. Clinical evaluation included pain level, size, erythema, and exudation of certain ulcers on 1st, 2nd, 4th and 6th days. Results A total of 47 subjects including 24 subjects in treatment group and 23 subjects in the control group fulfilled the study without obvious side effects. On 2nd, 4th and 6th days, the ulcer pain score of the treatment group decreased by 15.8%, 41.27% and 80.58%, respectively, while the control group decreased by 5.56%, 19.60% and 51.25%. Berberine gelatin treatment reduced the ulcer pain score compared with control group and there was significant difference between the two groups(P＜0.05) .The ulcer size of treatment group decreased by28.36%, 48.63% and 72.72%,respectively, while the control group decreased by 11.41%, 25.77% and 50.92%, The ulcer size was significantly reduced in treatment group (P＜0.05) .On the 2nd day, there was no difference in congestion and exudation between two groups (P＞0.05).On 4th and 6th days, the erythema and exudation of the treatment group significantly reduced (P＜0.05) (P＜0.05)compared with control group. No obvious adverse reaction was found. Conclusion Berberine gelatin can promote the healing of MiRAU and relieve the pain . It has good clinical effects and may be a safe and effective local administration for MiRAU.

Key words: Berberine gelatin, recurrent aphthous ulcer, efficacy