Thinking and Practice in the Design of Clinical Trial Schemes for the Treatment of COVID-19 with Traditional Chinese Medicine: A Study Protocol

Zhenxuan Li, Yu-min Du, Xiaolong Xu, Qingquan Liu
{"title":"Thinking and Practice in the Design of Clinical Trial Schemes for the Treatment of COVID-19 with Traditional Chinese Medicine: A Study Protocol","authors":"Zhenxuan Li, Yu-min Du, Xiaolong Xu, Qingquan Liu","doi":"10.14218/fim.2023.00008","DOIUrl":null,"url":null,"abstract":"Background and objectives: This study aimed to determine the key points in the design of clinical trial protocols for coronavirus disease 2019 (COVID-19) following the PICOS principle. Methods: A randomized, double-blind, placebo-controlled study of Cangma Huadu Granules in the treatment of mild COV-ID-19 will be carried out. Discussion: We recommend a randomized controlled trial as the study type. The inclusion criteria should not only define the diagnostic criteria of Western medicine and the syndrome types of Chinese medicine but also define the course of the disease. The definition of high-risk groups in the exclusion criteria needs to specify the diseases and laboratory test indicators to avoid excluding patients with common underlying diseases. Preclinical studies on the experimental product and the traditional Chinese medicine theory of indications should be outlined to clarify the trial rationale. A placebo combined with basic treatment is recommended as a control. Outcomes can refer to the core outcome set for clinical trials on COVID-19, and it is recommended to set the main outcome indicators around the clinical symptoms. In addition, homogeneous Chinese medicine during the ex-periment should be avoided, and the online registration should be completed in a timely manner. Trial Registration","PeriodicalId":73126,"journal":{"name":"Future integrative medicine","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Future integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14218/fim.2023.00008","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Background and objectives: This study aimed to determine the key points in the design of clinical trial protocols for coronavirus disease 2019 (COVID-19) following the PICOS principle. Methods: A randomized, double-blind, placebo-controlled study of Cangma Huadu Granules in the treatment of mild COV-ID-19 will be carried out. Discussion: We recommend a randomized controlled trial as the study type. The inclusion criteria should not only define the diagnostic criteria of Western medicine and the syndrome types of Chinese medicine but also define the course of the disease. The definition of high-risk groups in the exclusion criteria needs to specify the diseases and laboratory test indicators to avoid excluding patients with common underlying diseases. Preclinical studies on the experimental product and the traditional Chinese medicine theory of indications should be outlined to clarify the trial rationale. A placebo combined with basic treatment is recommended as a control. Outcomes can refer to the core outcome set for clinical trials on COVID-19, and it is recommended to set the main outcome indicators around the clinical symptoms. In addition, homogeneous Chinese medicine during the ex-periment should be avoided, and the online registration should be completed in a timely manner. Trial Registration
中医药治疗新冠肺炎临床试验方案设计的思考与实践
背景与目的:本研究旨在根据PICOS原则确定2019冠状病毒病(COVID-19)临床试验方案设计的关键点。方法:采用随机、双盲、安慰剂对照的方法,研究苍马花都颗粒治疗轻症covid -19的疗效。讨论:我们推荐随机对照试验作为研究类型。纳入标准既要明确西医诊断标准和中医证型,又要明确病程。排除标准中对高危人群的定义需要明确疾病和实验室检测指标,避免排除有常见基础疾病的患者。应概述实验产品的临床前研究和中医适应症理论,以阐明试验的基本原理。作为对照,推荐使用安慰剂联合基础治疗。结局可参照新冠肺炎临床试验的核心结局设置,建议围绕临床症状设置主要结局指标。此外,实验过程中应避免使用同质中药,并及时完成网上注册。试验注册
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信