At the 73rd Academic Conference of the Japan Society for Oriental Medicine held in June 2023, a report on an establishment of evidence for the coronavirus disease-2019 (COVID-19) was presented. As part of this project, we reported how we conducted the observational study and the clinical trial that evaluated the effectiveness of Kampo medicine on the acute symptoms of mild to moderate COVID-19 patients. In this article, we have summarized our experience in these studies from the viewpoint of a statistician, including important things to be considered when writing a research plan and selecting endpoints and statistical analysis methods.
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