Efficacy of Traditional Chinese Medicine, Maxingshigan-Weijing in the management of COVID-19 patients with severe acute respiratory syndrome: A structured summary of a study protocol for a randomized controlled trial

doi:10.1186/s13063-020-04970-3

科研成果详情

名称	Efficacy of Traditional Chinese Medicine, Maxingshigan-Weijing in the management of COVID-19 patients with severe acute respiratory syndrome: A structured summary of a study protocol for a randomized controlled trial
作者	Zeng, Congcong 1; Yuan, Zhengzhong1; Pan, Xiaoqiong2,3; Zhang, Jizhou 4; Zhu, Jiahui5; Zhou, Fan 6; Shan, Zhuocheng 1; Yuan, Ye5; Ye, Ren1; Cheng, Jinguo5
发表期刊	TRIALS
语种	英语
原始文献类型	Letter
关键词	COVID-19 Randomized controlled trial protocol Traditional Chinese medicine Maxingshigan-weijing Symptom
摘要	Objectives We aimed to test our expectation that additional administration of Traditional Chinese medicine (TCM), maxingshigan-weijing decoction, is more effective in the management of COVID-19 patients compared to those treated with routine supportive care alone. Trial design This is a multicenter, open-label 2-arm (1:1 ratio) randomized controlled trial. Participants Patients will be recruited from 3 hospitals in Wenzhou China: the First Affiliated Hospital of Wenzhou Medical University, the Second Affiliated Hospital of Wenzhou Medical University and Wenzhou Center Hospital. The inclusion and exclusion criteria are as follows: Inclusion criteria 1. Participants are 18-85 years of age, either male or female. 2. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3. Symptomatic. Mild (mild clinical symptoms without signs of pneumonia in chest X-ray) and Moderate (fever or respiratory symptom with signs of pneumonia in chest X-ray) . 1. Signed the informed consent before treatment. 2. Agreed not to enroll in any other clinical trials. 3. Inpatients Exclusion criteria 1. < 18 or > 85 years old. 2. Pregnancy and lactation. 3. Serious heart, liver, kidney and hematopoietic system diseases, abnormal liver or kidney function. 4. Suffering from other known virus pneumonia. 5. Allergic to Chinese herbal medicine or suffering from allergies. 6. Critical patients (respiratory failure treated by mechanical ventilation or shock or multiple organ failure). Intervention and comparator Patients in the control group will receive routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in TCM group will be asked to take maxingshigan-weijing decoction (composed of 14 Chinese herbal medicines), orally 200 mL 2 times daily, for 14 consecutive days in addition to routine supportive care as mentioned above. Maxingshigan-weijing decoction consists of 10 g of Herba Ephedra (Mahuang), 10 g of Amygdalus Communis Vas (Xingren), 45 g of Gypsum Fibrosum (Shigao), 30 g of Rhizoma phragmitis (Lugen), 20 g of Peach kernel (Taoren), 20 g of Winter Melon kernel (Dongguaren), 30 g of Trichosanthes Kirilowii Maxim (Gualou), 12 g of Pericarpium Citri Reticulatae (Chenpi), 12 g of Rhizoma Pinelliae (Jiangbanxia), 12 g of caulis bambusae in taeniis (Zhuru), 30 g of semen lepidii (Tingliz), 15 g of semen lepidii (Shichangpu), 10 g of curcuma zedoary (ezhu) and 5 g of Radix Glycyrrhizae (Gancao). Main outcomes The primary outcome will be the number of days until the clinical symptom of fever improves in the first 14 days of treatment following randomisation. Fever will be defined as an improvement when the temperature is less than 37 degrees C. Secondary outcomes will be TCM Syndrome Scores, the time it takes until individuals have negative test results for SARS-CoV-2 nucleic acid, the proportion of cases with chest X-ray improvements and the rate of symptom (fever, cough, malaise, shortness of breath) recovery. TCM Syndrome Scoring System is a checklist covering 4 main, 7 secondary and 13 accompanying items. The 4 main items consisting of fever, cough, malaise and shortness of breath, use a four-point scale (0, 2, 4 and 6) depending on the severity; the 7 secondary items including dysphoria, diarrhea, pharyngalgia, expectoration, muscular soreness, nasal obstruction and rhinorrhoea use 0-3-point scale; the 13 accompanying items contain chest pain, headache, aversion to cold, dizziness, nausea and vomiting, anorexia, abdominal distension, dry mouth, anxiety, spontaneous sweating, insomnia, wheezing and blood tinged sputum, and each item is rated on 0-1 scale ( 0 stands for asymptomatic, 1 stands for symptomatic ). The total scores sum up to a range from 0 to 58, with higher scores indicating more severe levels of disease. Randomization Minimization method will be used, balancing the two arms for pneumonia severity. Patients are randomized (1:1 ratio) to each group. Clinical researchers will get a random sequence number which is automatically generated by a random number generator (IBM Corp., Armonk, NY, USA), and sequentially number them in an opaque envelope. Researchers will open random allocation envelopes and assign participants accordingly. Eligible patients will be randomly divided into a routine supportive care group and a routine supportive care plus oral administration of traditional Chinese medicine group, with 70 patients in each group. Blinding (masking) This is an open-label study. The statistical analysis will be carried out by the Professor of Statistics at Wenzhou Medical University, who is blinded to patient allocation. Numbers to be randomised (sample size) The previous study reported the efficacy of TCM for COVID-19 and H1N1 influenza patients, the median survival time in the TCM group is estimated as 3 days; this time will be 1.5 times longer in the control group. Accordingly, Kaplan-Meier method and log-rank test will be used. And assuming a statistical power of 70% (one-sided type-1 error of alpha = 5%, beta = 30%) and a rate of withdrawal and loss to follow-up of 10%, we plan to include 140 participants in both groups ( TCM group = 70, control group = 70). Trial Status The trial protocol is Version 2.0, October 14, 2020. Recruitment began March, 2020, and is anticipated to be completed by December 31, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
资助项目	Wenzhou Municipal Science and Technology Bureau (CN) [ZY202003]
出版者	BMC
出版地	LONDON
ISSN	1745-6215
EISSN	1745-6215
卷号	21
期号	1
DOI	10.1186/s13063-020-04970-3
页数	3
WOS类目	Medicine, Research & Experimental
WOS研究方向	Research & Experimental Medicine
WOS记录号	WOS:000603022100001
收录类别	SCIE ; SCOPUS
发布日期	2020-12-23
URL	查看原文
PubMed ID	33357239
通讯作者地址	[Ye, Ren]Wenzhou Med Univ, Affiliated Hosp 1, Dept Tradit Chinese Med, Wenzhou 325035, Zhejiang, Peoples R China. ; [Cheng, Jinguo]Wenzhou Med Univ, Chashan Higher Educ Pk, Wenzhou 325035, Zhejiang, Peoples R China.
Scopus学科分类	Medicine (miscellaneous);Pharmacology (medical)
SCOPUSEID	2-s2.0-85098603149
引用统计	被引频次：4[WOS] [WOS记录] [WOS相关记录]
文献类型	其他
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/32798
专题	附属第一医院_中医科温州医科大学第二临床医学院，附属第二医院、育英儿童医院附属第二医院_中医科
通讯作者	Ye, Ren; Cheng, Jinguo
作者单位	1.Wenzhou Med Univ, Affiliated Hosp 1, Dept Tradit Chinese Med, Wenzhou 325035, Zhejiang, Peoples R China; 2.Wenzhou Med Univ, Affiliated Hosp 2, Dept Tradit Chinese Med, Wenzhou 325200, Zhejiang, Peoples R China; 3.Wenzhou Med Univ, Yuying Childrens Hosp, Wenzhou 325200, Zhejiang, Peoples R China; 4.Wenzhou Hosp Tradit Chinese Med, Wenzhou 325035, Zhejiang, Peoples R China; 5.Wenzhou Med Univ, Chashan Higher Educ Pk, Wenzhou 325035, Zhejiang, Peoples R China; 6.Wenzhou Ctr Hosp, Dept Tradit Chinese Med, Wenzhou 325200, Zhejiang, Peoples R China
第一作者单位	附属第一医院_中医科
通讯作者单位	附属第一医院_中医科; 温州医科大学
推荐引用方式 GB/T 7714	Zeng, Congcong,Yuan, Zhengzhong,Pan, Xiaoqiong,et al. Efficacy of Traditional Chinese Medicine, Maxingshigan-Weijing in the management of COVID-19 patients with severe acute respiratory syndrome: A structured summary of a study protocol for a randomized controlled trial. 2020.