Phase â…¡ Clinical Trial Study Of The Treatment Of Cough Syndrome Of Wind-heat Invading Lung With Baobeizhike Oral Solution

Objective:The safty and efficient evaluation on treatment of cough syndrome of wind-heatinvading lung (Acute bronchitis,acute exacerbation of chronic bronchitis)withBaobeizhike oral solution by phase II clinical trial, and prepared important basis forphase Ⅲclinical research.Methods:The methods of this trial involved Positive parallel control, randomized doubleblind and double dummy, multi clinical center study. There are240cases aged18～65patients in all, which randomly divided into two groups. All of them are up to thestandard of cough syndrome of wind-heat invading lung (Acute bronchitis,acuteexacerbation of chronic bronchitis). The treatment group takes2Baobeizhike oralsolution each time and3times every day, and takes acute bronchitis syrup assimulation20ml each time and3times every day at the same time, the course of thetreatment is7days. The control group takes acute bronchitis syrup20ml each timeand3times every day, and takes2Baobeizhike oral solution as simulation each timeand3times every day, the course of the treatment is7days. The major efficacy indexis cough and expectoration. Averse to wind, efficacy of traditional chinese medicinesyndrome and nasal discharge as sub-efficacy index. Observing the improvement ofthe two groups and comparing the clinical efficacy of the two groups. Statisticanalysis is done by SAS8.2statistic analysis software.Results:1. The statistic analysis of demography and clinical features indicated no statisticdifference between the two groups.2. The cure rate of efficacy of traditional chinese medicine syndrome intreatment group was25.00%, and the control group was20.83%. There was no statistic significance between the two groups（P>0.05）.3. The cure rate of cough was38.33%and37.50%in the treatment group andcontrol group respectively. The cure rate of expectoration was65.83%and59.66%inthe treatment group and control group respectively. There was no statistic significancein both major symptoms（P>0.05）.4.There was no statistic significance in the efficacy of the sub-symptoms,including Averse to wind, nasal discharge, pharyngalgia, dry mouth, chest stuffiness,yellow urine and dry stool, excepted chest stuffiness and yellow urine（P>0.05）.5. There was no statistic significance in the rate of adverse event/reaction（P>0.05）. There was no death and non-fatal serious adverse event.Conclusion:There was no difference between the efficacy of Baobeizhike oral solution andacute bronchitis syrup, based on the major efficacy index (cough and expectoration)and sub-efficacy index (chinese traditional medicine symptom and averse to wind etc).There was no difference between the two groups, comparing the rate of adverseevent/reaction. The result of comprehensive evaluation indicated the treatment ofcough syndrome of wind-heat invading lung (Acute bronchitis, acute exacerbationof chronic bronchitis) with Baobeizhike oral solution was not inferior to acutebronchitis syrup. All the data demonstrated that Baobeizhike oral solution was worthto expand clinical utilization.