Novel coronavirus pneumonia (COVID-19) combined with Chinese and Western medicine based on ”Internal and External Relieving -Truncated Torsion” strategy

INTRODUCTION: The outbreak of novel coronavirus disease 2019 (COVID-19) has caused a global pandemic since December 2020. It has not only associated with physiological disorder but also with psychological distress and symptoms of mental illness. Whether the vaccines and antivirals can provide protects remains unknown. Traditional Chinese medicine (TCM) is recommended as an alternative and significant way of preventing and treating COVID-19 in China. However, few studies have assessed the benefits of this treatment and mental health after they recover. Our study is designed to investigate effects and safety when using TCM on the course of this disease and the impact of COVID-19 on pandemic-related anxiety. METHOD: For this prospective cohort study, we will enroll 300 COVID-19 patients aged 18 to 80 years at 4 centers. We divide them into 2 groups, according to whether they use Baidu Jieduan Granule at a ratio of 1:1. We will compare treatments combined Baidu Jieduan Granule with conventional Western medicine (experimental group) vs treatment of conventional Western medicine only (control group). The basic information of patients including demographic, general condition, primary diseases, and complications will be assessed. Related examines will be conducted at 1, 3, 5, 7, and 14 days. The primary outcomes are clinical outcome. A follow-up time of 1 year (to June 30, 2021) allow us to evaluate the psychiatric disorder after recovery. We will monitor adverse events throughout the trial. DISCUSSION: It will be the first prospective cohort study which uses Baidu Jieduan Granule, based on the innovation traditional Chinese medicine strategy of “ Internal and External Relieving -Truncated Torsion ” to treat the common type of COVID-19. The result of this study may provide evidence-based recommendations of TCM for treatment and psychological distress or symptoms of mental illness of the common type of COVID-19.