Randomized Double-Blind Multicenter Study on Xuanfei Zhisou Mixture(宣肺止嗽合剂)in Treatment of Acute Bronchitis(Wind Evil Invading Lung Type)
Objective To observe the impacts of Xuanfei Zhisou Mixture(宣肺止嗽合剂)on TCM syndromes and quality of life of patients with acute bronchitis of wind evil invading lung type.Methods Randomized,controlled and placebo-controlled parallel trial design was adopted.The observation was conducted in 19 parallel centers,and 240 cases were randomly divided in-to trial group and control group,with 120 cases in each group.The trial group was administered with Xuanfei Zhisou Mixture,while the control group was given Xuanfei Zhisou Mixture simulation agent.The treatment course was 7 days.The scores of TCM syndromes(daytime cough,night cough,expectoration,itchy throat)and Leicester cough quality of life questionnaire(LCQ)were compared.Results There were 232 cases completed this trial,including 118 cases in the trial group and 114 cases in the control group.After treatment,the TCM syndromes scores decreased,and physiological score,psychological score,social score and total score of LCQ increased in both groups,and the trial group showed more significant changes(P＜0.01).The difference between the two groups of the above indicators after treatment and baseline was statistically significant(P＜0.01).The results of the full analysis set(FAS)and per protocol set(PPS)were consistent.Conclusion Xuanfei Zhisou Mixture could significantly im-prove the TCM syndromes of patients with acute bronchitis(wind evil invading lung type)and increase the quality of life of the patients.
Xuanfei Zhisou Mixture(宣肺止嗽合剂)acute bronchitiswind evil invading lungTCM syndromesquality of life
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