Chinese herbal medicine Shufeng Jiedu Capsule for patients with mild to moderate coronavirus disease 2019 (COVID-19): Protocol for a randomized, blinded, placebo control trial

World Health Organization, COVID-19 Dashboard. https://covid19.who.int/, 2020 (accessed 14 June 2023). Iacobucci, 2022, Covid-19: UK adds sore throat, headache, fatigue, and six other symptoms to official list, BMJ, 377, o892, 10.1136/bmj.o892 World Health Organization, Coronavirus disease (COVID-19). https://www.who.int/health-topics/coronavirus#tab=tab_1, 2020 (accessed 30 August 2022). National Medical Products Administration, Announcement of the National Food and Drug Administration on the Conversion of 4 Kinds of medicines including Shufeng Jiedu Capsule into over-the-counter drugs (No. 90 of 2021). https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20210707173856142.html, 2021 (accessed 30 August 2022). Tao, 2017, Therapeutic Mechanistic Studies of ShuFengJieDu Capsule in an Acute Lung Injury Animal Model Using Quantitative Proteomics Technology, J. Proteome Res., 16, 4009, 10.1021/acs.jproteome.7b00409 Yuan, 2018, Shufeng Jiedu Capsules Alleviate Lipopolysaccharide-Induced Acute Lung Inflammatory Injury via Activation of GPR18 by Verbenalin, Cell. Physiol. Biochem., 50, 629, 10.1159/000494184 Xia, 2018, Shufeng Jiedu Capsule and its active ingredients induce apoptosis, inhibit migration and invasion, and enhances doxorubicin therapeutic efficacy in hepatocellular carcinoma, Biomed. Pharmacother., 99, 921, 10.1016/j.biopha.2018.01.163 Cai, 2022, Shufeng Jiedu capsule inhibits inflammation and apoptosis by activating A2AAR and inhibiting NF-κB to alleviate LPS-induced ALI, J. Ethnopharmacol., 298, 10.1016/j.jep.2022.115661 Bao, 2016, Effect of Shufeng Jiedu capsules as a broad-spectrum antibacterial, Biosci Trends, 10, 74, 10.5582/bst.2015.01172 Zhuang, 2021, Exploring the Potential Mechanism of Shufeng Jiedu Capsule for Treating COVID-19 by Comprehensive Network Pharmacological Approaches and Molecular Docking Validation, Comb. Chem. High Throughput Screen., 24, 1377, 10.2174/1386207323999201029122301 Ji, 2020, Unique synergistic antiviral effects of Shufeng Jiedu Capsule and oseltamivir in influenza A viral-induced acute exacerbation of chronic obstructive pulmonary disease, Biomed. Pharmacother., 121, 10.1016/j.biopha.2019.109652 Liao, 2021, Shufeng Jiedu capsules protect rats against LPS-induced acute lung injury via activating NRF2-associated antioxidant pathway, Histol. Histopathol., 36, 317 Tao, 2020, Systematic analyses on the potential immune and anti-inflammatory mechanisms of Shufeng Jiedu Capsule against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-caused pneumonia, J. Funct. Foods, 75, 10.1016/j.jff.2020.104243 Xiong, 2020, Analysis of the mechanism of Shufeng Jiedu capsule prevention and treatment for COVID-19 by network pharmacology tools, Eur J Integr Med, 40, 10.1016/j.eujim.2020.101241 2022, Guidelines for the diagnosis and treatment of coronavirus Disease 2019 (Trial version ninth), Chinese Journal of Viral Diseases, 17, 481 Zhuang, 2020, Chinese Patent Medicines in the Treatment of Coronavirus Disease 2019 (COVID-19) in China, Front. Pharmacol., 11, 1066, 10.3389/fphar.2020.01066 Zhang, 2022, Chinese Patent Medicine Shufeng Jiedu Capsules as an Adjuvant Therapy for Community-Acquired Pneumonia: a Systematic Review and Meta-Analysis of Randomized Clinical Trials, Front. Pharmacol., 13 Xu, 2022, Overview of systematic reviews of Shufeng Jiedu Capsules, Zhongguo Zhong Yao Za Zhi, 47, 1103 Xia, 2020, Shufeng Jiedu capsules for treating acute exacerbations of chronic obstructive pulmonary disease: a systematic review and meta-analysis, BMC Complement Med Ther, 20, 151, 10.1186/s12906-020-02924-5 Sheng, 2022, The add-on effect of Shufeng Jiedu capsule for treating COVID-19: a systematic review and meta-analysis, Front Med (Lausanne), 9 Xu, 2022, Potential therapeutic effect of Shufeng Jiedu capsule and its major herbs on coronavirus disease 2019 (COVID-19): a review, Drug Discov Ther, 15, 289, 10.5582/ddt.2021.01099 Chan, 2013, SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials, BMJ, 346, e7586, 10.1136/bmj.e7586 Schulz, 2010, CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials, BMJ, 340, c332, 10.1136/bmj.c332 Hayden, 2018, Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents, N. Engl. J. Med., 379, 913, 10.1056/NEJMoa1716197 Treanor, 2000, Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial, JAMA, 283, 1016, 10.1001/jama.283.8.1016 Clemency, 2022, Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: a Randomized Clinical Trial, JAMA Intern Med, 182, 42, 10.1001/jamainternmed.2021.6759 Liu, 2021, Comparison of Antiviral Agents for Seasonal Influenza Outcomes in Healthy Adults and Children: a Systematic Review and Network Meta-analysis, JAMA Netw. Open, 4, 10.1001/jamanetworkopen.2021.19151 López-Medina, 2021, Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: a Randomized Clinical Trial, JAMA, 325, 1426, 10.1001/jama.2021.3071 Rocco, 2021, Early use of nitazoxanide in mild COVID-19 disease: randomised, placebo-controlled trial, Eur. Respir. J., 58, 10.1183/13993003.03725-2020 Faul, 2007, G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences, Behav Res Methods, 39, 175, 10.3758/BF03193146 Xia, 2021, Shufeng Jiedu, a promising herbal therapy for moderate COVID-19:antiviral and anti-inflammatory properties, pathways of bioactive compounds, and a clinical real-world pragmatic study, Phytomedicine, 85, 10.1016/j.phymed.2020.153390 Zhang, 2022, Treating patients infected with the SARS-CoV-2 Omicron variant with a traditional Chinese medicine, Shufeng Jiedu capsule, Biosci Trends, 16, 238, 10.5582/bst.2022.01220 Wang, 2020, Clinical characteristics and therapeutic procedure for four cases with 2019 novel coronavirus pneumonia receiving combined Chinese and Western medicine treatment, Biosci Trends, 14, 64, 10.5582/bst.2020.01030 Chen, 2021, Clinical evaluation of Shufeng Jiedu Capsules combined with umifenovir (Arbidol) in the treatment of common-type COVID-19: a retrospective study, Expert Rev Respir Med, 15, 257, 10.1080/17476348.2020.1822741 Wild, 2021, Understanding the burden of interstitial lung disease post-COVID-19: the UK Interstitial Lung Disease-Long COVID Study (UKILD-Long COVID), BMJ Open Respir Res, 8, 10.1136/bmjresp-2021-001049