Influence of Xuanfei Zhisou Mixture(宣肺止嗽合剂)on Traditional Chinese Medicine Symptoms and Quality of Life for Post Infectious Cough(Wind Evil Invading Lung Type):A Randomized,Double-Blinded,Placebo,Parallel-Controlled Multicenter Trial
Objective To observe the influence of Xuanfei Zhisou Mixture(宣肺止嗽合剂)on traditional Chinese medicine symptoms and quality of life for post infectious cough of wind evil invading lung type.Methods A randomized,controlled,placebo-controlled,multi-center clinical trial was conducted.A total of 240 cases were divided into trial group(120 cases)and control group(120 cases)at a ratio of 1∶1.The trial group was administered with Xuanfei Zhisou Mixture,while the control group was given Xuanfei Zhisou Mixture simulation agent,both with 20 mL each time,three times a day,and the treatment course was 7 days.The TCM syndromes(daytime cough,night cough,expectoration,itchy throat)scores,and Leicester cough quality of life questionnaire(physiological score,psychological score,social score and total score)were compared.Full analysis set(FAS)and per protocol set(PPS)were used for the analysis.Results There were 238 subjects in the FAS(with 119 cases in each group),and 227 subjects in the PPS(with 114 cases in trial group and 113 cases in control group).PPS and FAS analyses showed that after treatment,the TCM syndromes scores decreased,while LCQ scores increased in both groups,and the trial group showed more significant changes(P＜0.01).Between groups,the differences after treatment and the differences from baseline af-ter treatment all showed statistical significance(P＜0.01).Conclusion Xuanfei Zhisou Mixture could significantly improve the TCM syndromes of patients with wind evil invading lung type,and increase their quality of life.
post infectious coughwind evil invading lungXuanfei Zhisou Mixture(宣肺止嗽合剂)TCM syndromesquali-ty of life
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