Study Protocol: A Randomized Multicenter Study on Clinical-efficacy Evaluation of Xiaoer Dingchuan Granule in Children with Respiratory Syncytial-virus Pneumonia

Abstract

Abstract Background Respiratory syncytial virus (RSV) pneumonia is a major cause of hospitalization in children worldwide, seriously endangering child health. In recent years, many clinical studies have shown that traditional Chinese medicine (TCM) has unique advantages in the treatment of pediatric viral pneumonia. Therefore, it is particularly important to strengthen exploration of and research into the use of TCM to treat RSV pneumonia in children. The aims of this study will be to evaluate the clinical effect of Xiaoer Dingchuan Granule (XDG) on RSV pneumonia and to provide a scientific basis for clinical diagnosis and treatment. Methods and Design: This study will be a single-blinded, parallel-controlled, multicenter randomized clinical trial (RCT) conducted in 10 Class III Grade A hospitals nationwide. We will recruit the study population from children aged 1–5 years who have been diagnosed with RSV pneumonia by Western medicine and with pneumonia and cough by TCM (phlegm-heat blocking lung syndrome) with a disease course within 48 h. The children’s parents or guardians will sign their informed consent. A total of 240 children will be recruited and divided into an experimental group and a control group. The control group will receive basic treatment, and the experimental group will receive XDG. Children will be treated for 7 days, and changes in their conditions will be evaluated daily and input to the medical-record observation form. We will follow-up on them at 10 and 90 days after discharge to observe their prognosis. After data collection, we will comprehensively evaluate the clinical efficacy of pediatric XDG as intervention into syncytial-virus pneumonia by its total effective rate, the curative-effect time window of pediatric pneumonia, the curative effect of TCM syndrome, changes in individual symptoms, changes in pulmonary signs, and the use of drug combinations. Discussion We speculate that treatment of RSV pneumonia in children with TCM can increase the overall clinical efficiency, alleviate disease severity, shorten hospital stays, reduce pain, and improve the children’s quality of life. Trial Registration: Chinese Clinical Trial Registry No. ChiCTR2200061471