[The phase Ⅱ clinical trial of Yanhouqing buccal tablets in the treatment of acute pharyngitis of external wind heat type]

Abstract

Objective:The aim of this study is to preliminary evaluate the clinical efficacy and safety of Yanhouqing buccal tablets in the treatment of acute pharyngitis of external wind heat type and explore the safe and effective dose. Method:Design of multi-center clinical trial with randomized, double-blind, single-analog, placebo-controlled, dose exploration. 288 patients were divided into three groups: low dose group, high dose group and placebo group. The effectiveness evaluation indexes was analysis of pharyngalgia or odynophagia, throat burning, TCM syndrome and pharyngeal signs, and the safety was evaluated by vital sign, lab examination indexes and adverse events. Result:The results showed that there was the statistically significant difference between high/low dose group and placebo group(P <0.01), and no significant difference between high and low dose groups(P >0.01) among the effectiveness evaluation indexes. There were no serious adverse events. The adverse events and adverse reactions in the three groups has no statistical significance(P >0.05). Conclusion:Yanhouqing buccal tablets is safe and effective in the treatment of acute pharyngitis of external wind heat type. We recommend 8 tablets per day and treat for 5 days in phase Ⅲ clinical trials.

Keywords: buccal tablets; clinical trial; pharyngitis.