| Objective:To evaluate the effectiveness and safety of Pediatric Jingxing Zhike Granule in the treatment of acute bronchitis by wind-cold transforming to heat pattern.Methods:Via the use of randomized,double-blind, parallel control,multi-center clinical trial methods,from the clinical perspective of children meeting the diagnostic criteria,90 patients were divided into low dose group,middle dose group and high dose group,30 cases in each group,after taking five days to observe for efficacy assessment.Meanwhile,to evaluate its security by observing the blood, urine, stool, heart, liver, kidney function and adverse reactions.Results:The efficacy of the three groups shows that:The total efficiency of the low dose group is 26.70%, middle dose group83.3%and high dose group 90.00%;the recovered efficiency of the low dose group is6.67%, middle dose group60.00%and high dose group73.30%.There are obviously significant differences between the middle dose group and low dose group,and the same as high dose group,no significant differences between the middle dose group and high dose group. the middle dose group and high dose group can improve many symptoms,such as cough, pulmonary auscultation,expectoration,sore throat,itchy throat,red throat,anorexia symptoms.on the regard of onset time of cough,middle dose groupis better than low dose group,high dose groupis better than middle dose group,showing a dose-effect relationship among the three groups.There are no abnormal changes of blood, urine, stool, liver and kidney function and ECG before and after treatments,Adverse reactions are also not found.Conclusion:The middle dose group and the high dose group of Pediatric Jingxing Zhike Granule are concluded as significantly effective with no observed side-effects. |