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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 )
Author(s) -
Takayama Shin,
Kashima Masayuki,
Namiki Takao,
Ito Takashi,
Ono Rie,
Arita Ryutaro,
Saito Natsumi,
Nakae Hajime,
Irie Yasuhito,
Kobayashi Seiichi,
Yoshino Tetsuhiro,
Ishigami Tomoaki,
Tanaka Koichiro,
Nogami Tatsuya,
Minakawa Satoko,
Nagase Mahiko,
Kashio Akihiko,
Ishige Tatsuya,
Maehara Hirofumi,
Saito Toshiaki,
Sempuku Sadahiro,
Yamazaki Mayuko,
Tahara Eiichi,
Suda Norio,
Nakamoto Kayo,
Mitsuma Tadamichi,
Sato Hiroko,
Shimooki Osamu,
Nakada Yoshinobu,
Abe Shuichi,
Masuda Takuya,
Kai Hiroki,
Yokota Kenichi,
Chiba Shigeki,
Saitoh Fumihiro,
Tanaka Yutaka,
Koizumi Sayaka,
Fujii Susumu,
Katori Rie,
Kainuma Mosaburo,
Nochioka Kotaro,
Chiu ShihWei,
Kikuchi Akiko,
Suzuki Tomoko,
Mimura Masaru,
Yamaguchi Takuhiro,
Ishii Tadashi
Publication year - 2021
Publication title -
traditional and kampo medicine
Language(s) - English
Resource type - Journals
ISSN - 2053-4515
DOI - 10.1002/tkm2.1271
Subject(s) - medicine , observational study , kampo , retrospective cohort study , diarrhea , alternative medicine , pathology
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.