Conventional and Kampo medicine in the treatment of mild to moderate COVID‐19: A multicenter, retrospective observational study protocol by the Integrative Management in Japan for Epidemic Disease (IMJEDI study‐Observation)

Abstract

Aim We present the study protocol of a multicenter, retrospective observational study that aims to investigate the efficacy of the actual treatment (the efficacy of conventional and Kampo medicines) of patients with mild to moderate or suspected coronavirus disease (COVID‐19). Methods This study is designed as a multicenter, retrospective observational study. Outpatients and inpatients will be recruited from Japanese hospitals. The inclusion criteria are as follows: having or suspected to have COVID‐19, mild to moderate COVID‐19, symptomatic, ≥20 years of age, male or female, able to communicate in Japanese, and treated with conventional and Kampo medicine. The exclusion criteria are: unable to provide informed consent due to dementia, psychosis, or psychiatric symptoms, severe COVID‐19, or determined unsuitable for this study. The sample size is set at 1000, as this number of people can be treated at the collaborating medical institutions during the study period. Results The main outcome is the number of days without fever, with a body temperature of less than 37°C. The secondary outcome is set at common cold‐like symptoms other than fever (fatigue, cough, shortness of breath, sputum, diarrhea) and severity of illness and hospitalization up to 14 days after the visit. Trial registration The trial was registered in the University Hospital Medical Information Network (Reservation No. UMIN000041301) on August 4, 2020. Conclusion Our study will explore the contribution of conventional and Kampo medicine in the treatment of patients with mild and moderate COVID‐19.

Kampo Medicine Promotes Early Recovery From Coronavirus Disease 2019-Related Olfactory Dysfunction: A Retrospective Observational Study

“…Thus, prospective studies are warranted to address these limitations. We are currently conducting multicenter clinical trials to demonstrate the efficacy and safety of Kampo medicine for COVID-19 ( Takayama et al, 2020 ; Takayama et al, 2021b ; Namiki et al, 2021 ).…”

Prevention and Recovery of COVID-19 Patients With Kampo Medicine: Review of Case Reports and Ongoing Clinical Trials

“…The JSOM has prepared a research project for clinical trials of Kampo medicine in patients with COVID-19 ( Takayama et al, 2020a ; Takayama et al, 2020c ; Namiki et al, 2021 ), some of which are currently in progress. Table 3 shows the list of the clinical studies being planned or conducted in the JSOM projects.…”

“…Study 2 is a multi-centered, retrospective, observational study to investigate the efficacy of the actual treatment (conventional and Kampo medicine) in patients with mild-to-moderate or even suspected COVID-19 ( Takayama et al, 2020a ). Several clinical trials on antiviral drugs are currently in progress; however, evidence on its efficacy remains limited.…”

Editorial: Potentials of Kampo Medicine in Modern Society

“…Kampo medicine might be applied to coronavirus disease 2019 (COVID-19) as well, since it has been used for viral infections such as influenza ( 12 ). Heat-clearing formula such as saikatsugekito is expected to prevent serious illness in mild cases ( 13 – 17 ). Tonic formula such as hochuekkito may prevent infections since it has multiple effects through the digestive and immune systems, including for acute viral infection and chronic inflammation ( 18 , 19 ).…”