The Effectiveness and Safety of the Treatment of Severe Pneumonia by Clearing away Lung Heat and Relieving Asthma: study protocol for a clinically randomized, controlled trial

Abstract

Abstract OBJECTIVE: Severe pneumonia (SP) is a common serious respiratory infectious disease that causes rapid changes in health and has a high fatality rate.To date, timely and effective anti-infection strategies and rational and scientific mechanical ventilation have failed to resolve early oxygenation conflicts in SP patients, and treatment is difficult. A clinical combination of traditional Chinese medicine (TCM) treatments is a feasible approach. This single-center RCT was designed to validate the safety and efficacy of a method for treating SP by clearing lung heat and relieving asthma. METHODS AND ANALYSIS: This is an ongoing single-center RCT to confirm the efficacy and safety of the method of clearing away lung heat and relieving asthma in treating SP. The study was initiated on September 24, 2022, and is scheduled to be completed on September 30, 2024. This trial collected 92 patients with SP admitted to Shuguang Hospital, affiliated with the Shanghai University of Traditional Chinese Medicine, and divided them into two groups in a ratio of 1:1 using a randomized number table. We obtained informed consent from the patients in the form of a written informed consent document signed by human participants. To develop a treatment regimen in addition to this prescription, the treatment group was referred to the Chinese guidelines for the diagnosis and treatment of community-acquired pneumonia in adults (2018 edition). The patients in the control group received only basic treatment for 12 ± 2 days, and they were observed for morbidity and mortality rates and safety indicators on day 28, and they were followed up on days 1, 3, 7, and 14 of treatment. SPSS 19.0 will be used for statistical analysis. All statistical tests will be two-sided. DISCUSSION: The trial suggested in this research attempts to construct a randomized, controlled clinical study to establish an evidence-based basis for developing a relatively single, clinically operable treatment and new drug development. Trial registration: A randomized and controlled study of Qingjin Pingchuan recipe in treating severe pneumonia, ChiCTR2200063694. Registered 14 September 2022, https://www.chictr.org.cn/showproj.html?proj=177431