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)

Shin Takayama*, Masayuki Kashima, Takao Namiki, Takashi Ito, Rie Ono, Ryutaro Arita, Natsumi Saito, Hajime Nakae, Yasuhito Irie, Seiichi Kobayashi, Tetsuhiro Yoshino, Tomoaki Ishigami, Koichiro Tanaka, Tatsuya Nogami, Satoko Minakawa, Mahiko Nagase, Akihiko Kashio, Tatsuya Ishige, Hirofumi Maehara, Toshiaki SaitoSadahiro Sempuku, Mayuko Yamazaki, Eiichi Tahara, Norio Suda, Kayo Nakamoto, Tadamichi Mitsuma, Hiroko Sato, Osamu Shimooki, Yoshinobu Nakada, Shuichi Abe, Takuya Masuda, Hiroki Kai, Kenichi Yokota, Shigeki Chiba, Fumihiro Saitoh, Yutaka Tanaka, Sayaka Koizumi, Susumu Fujii, Rie Katori, Mosaburo Kainuma, Kotaro Nochioka, Shih Wei Chiu, Akiko Kikuchi, Tomoko Suzuki, Masaru Mimura, Takuhiro Yamaguchi, Tadashi Ishii

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

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.

Original languageEnglish
Pages (from-to)106-110
Number of pages5
JournalTraditional & Kampo Medicine
Volume8
Issue number1
DOIs
StatePublished - 2021/04

Keywords

  • Conventional treatment, COVID-19, Kampo medicine, prevention for severe stage, protocol, retrospective observational study, symptom relief

ASJC Scopus subject areas

  • Complementary and alternative medicine
  • Pharmacology (medical)

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