Abstract: Objective  To further evaluate the effectiveness and safety of Xiaoer Jingxing Zhike granules in the treatment of pediatric acute bronchitis with coldinduced fever syndrome.
Methods  A randomized, parallel-controlled, double-blind, multicenter clinical trial design was used. A total of 479 patients with pediatric acute bronchitis with coldinduced fever syndrome were selected from 7 research centers. They were divided into experimental group and control group. The duration of treatment was 5 days. Symptoms and signs and comprehensive curative effect evaluation were taken as the main evaluation indicators for effectiveness, and adverse event/adverse reaction incidence and safety detection were taken as the main evaluation indicators for safety.
Results In terms of the total effective rate of disease curative effect, the experimental group(87.71%,307/350) was better than the control group(27.12%,32/118).In terms of the total effective rate of TCM symptoms, the experimental group (87.71%,307/350) was superior to the control group (28.81%,34/118).For the evaluation of the efficacy of disease and the total effectiveness of TCM symptoms, the difference between the two groups was statistically significant(P＜0.05). In terms of safety, Adverse reactions(mild allergy) occurred in 1 case in the experimental group, the incidence rate being  0.28%.
Conclusion The results of the phase III clinical trial further prove that Xiaoer Jingxing Zhike granules is safe and effective in the treatment of pediatric acute bronchitis with coldinduced fever syndrome.

Key words: Acute bronchitis, External cough, Cold-induced fever syndrome, Xiaoer Jingxing Zhike granules, Children