Title: A phase III clinical trial of oral ulcer buccal tablets in the treatment of recurrent aphthous ulcer
Abstract: Objective:To compare the effect of oral ulcer buccal tablets with oral ulcer powder in the treatment of recurrent aphthous ulcer(RAU).Methods:A multi-center randomized Phase Ⅲ clinical trial was conducted.312 cases of RAU were enrolled in the experimental group and 104 in the control.The patients in the experimental group were treated by oral ulcer buccal tablets and those in control by oral ulcer powder.The treatment was continued for 6 days,the effect was evaluated by median duration of RAU(MDR),daily healing ratio(DHR),decrease of pain index(DPI),pain control time(PCT)and effecient ratio(ER).Safety of the drugs was monitored by clinical lab examination and adverse event(AE)observation.Results:Treatment was completed in 306 experimental cases and 100 control cases respectively.In the experimental group MDR was shorter(6 vs 7 days),DHR higher(P0.05),DPI more(P0.05),PCT longer(P0.05),ER higher(P0.05)and drug related AE less(P0.05).All AE were mild and lab examination showed no obvious abnormal changes.Conclusion:Oral ulcer buccal tablet is more effective in the treatment of RAU.
Publication Year: 2010
Publication Date: 2010-01-01
Language: en
Type: article
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