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 COVID-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 experiment should be avoided, and the online registration should be completed in a timely manner.
Trial Registration Chinese Clinical Trial Registry, ChiCTR2300070933. Registered on 26 April 2023, www.chictr.org.cn.
Acknowledgments
None.
Funding
This work was supported by the National Interdisciplinary In-novation Team of TCM under the State Administration of TCM (ZYYCXTD-D-202201).
Conflict of interest
QQL has served as Co-editor-in-Chief, and XLX has been an editorial board member of Future Integrative Medicine since No-vember 2021. The other authors have declared that no competing interests exist.
Author contributions
ZXL and YD: Original draft preparation; XLX and QQL: Review-ing and Editing.
Ethical statement
This study followed the Declaration of Helsinki and was approved by the Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine (No. SL-2022BL02-089-02). Informed consent was obtained from all study participants, the trial registration num-ber in the Chinese clinical trial registry is ChiCTR2300070933 (www.chictr.org.cn).
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