Efficacy and Safety of Huashi Baidu Granules in the Treatment of Children Suffering from Influenza with Exterior-cold and Interior-heat Syndrome: A Multi-center, Randomized Controlled Trial Protocol.

Influenza is one of the major public health problems worldwide. Children are the high-risk group for influenza and the high-risk population with symptoms. Huashi Baidu(HSBD) Granules have played a great role in fighting against COVID-19. In recent decades, this recipe has also been applied by pediatricians to treat influenza, with remarkable curative effects. However, there is still a lack of high-quality evidence-based medical practice.This study was designed as a multi-center, randomized, parallel-controlled trial, with an estimated sample size of 520 children suffering from influenza with exterior-cold and interior-heat syndrome. All the enrolled children will be randomly assigned to a test group and a control group. Children in the test group were treated with Huashi Baidu Granules, and those in the control group were provided with Oseltamivir Phosphate Granules for intervention. The primary outcome measure was the time to clinical recovery, with the Chinese version of the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) score measured at baseline and every 24 hours after treatment, which was evaluated at the endpoint of follow-up. The secondary outcome was the time to complete fever remission, scores of CARIFS symptom dimensions and the area under the curve with time, the incidence of complications/severe/critical influenza, the rate of single symptom disappearance, and the therapeutic effect of traditional Chinese medicine syndromes, which were recorded at baseline and after treatment, and evaluated at the end of treatment. Safety and endpoint events were evaluated at the same time.This study is intended to apply Huashi Baidu Granules to treat influenza with exterior-cold and interior-heat syndrome to identify the clinical efficacy and safety of this recipe. Simultaneously, our study will also discuss the characteristics of clinical syndrome in traditional Chinese medicine and syndrome distribution of influenza in the studied children.