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Multicenter, randomized controlled trial of traditional Japanese medicine, kakkonto with shosaikotokakikyosekko, for mild and moderate coronavirus disease patients

Affiliation
Department of Education and Support for Regional Medicine (General and Kampo medicine) ,Tohoku University Hospital ,Sendai ,Japan
Takayama, Shin;
Affiliation
Department of Japanese-Oriental (Kampo) Medicine ,Graduate School of Medicine ,Chiba University ,Chiba ,Japan
Namiki, Takao;
Affiliation
Department of Education and Support for Regional Medicine (General and Kampo medicine) ,Tohoku University Hospital ,Sendai ,Japan
Arita, Ryutaro;
Affiliation
Department of Education and Support for Regional Medicine (General and Kampo medicine) ,Tohoku University Hospital ,Sendai ,Japan
Ono, Rie;
Affiliation
Department of Education and Support for Regional Medicine (General and Kampo medicine) ,Tohoku University Hospital ,Sendai ,Japan
Kikuchi, Akiko;
Affiliation
Department of Education and Support for Regional Medicine (General and Kampo medicine) ,Tohoku University Hospital ,Sendai ,Japan
Ohsawa, Minoru;
Affiliation
Department of Education and Support for Regional Medicine (General and Kampo medicine) ,Tohoku University Hospital ,Sendai ,Japan
Saito, Natsumi;
Affiliation
Department of Education and Support for Regional Medicine (General and Kampo medicine) ,Tohoku University Hospital ,Sendai ,Japan
Suzuki, Satoko;
Affiliation
Department of Emergency and Critical Care Medicine ,Akita University Graduate School of Medicine ,Akita ,Japan
Nakae, Hajime;
Affiliation
Department of Respiratory Medicine ,Japanese Red Cross Ishinomaki Hospital ,Ishinomaki ,Japan
Kobayashi, Seiichi;
Affiliation
Center for Kampo Medicine ,Keio University School of Medicine ,Tokyo ,Japan
Yoshino, Tetsuhiro;
Affiliation
Department of Cardiology ,Yokohama City University Hospital ,Yokohama ,Japan
Ishigami, Tomoaki;
Affiliation
Department of Traditional Medicine ,Faculty of Medicine ,Toho University ,Tokyo ,Japan
Tanaka, Koichiro;
Affiliation
Department of Cardiovascular Medicine ,Tohoku University Graduate School of Medicine ,Sendai ,Japan
Nochioka, Kotaro;
Affiliation
Clinical Research Data Center ,Tohoku University Hospital ,Sendai ,Japan
Takagi, Airi;
Affiliation
Center for Kampo Medicine ,Keio University School of Medicine ,Tokyo ,Japan
Mimura, Masaru;
Affiliation
Division of Biostatistics ,Tohoku University Graduate School of Medicine ,Sendai ,Japan
Yamaguchi, Takuhiro;
Affiliation
Department of Education and Support for Regional Medicine (General and Kampo medicine) ,Tohoku University Hospital ,Sendai ,Japan
Ishii, Tadashi;
Affiliation
Hospital Bando ,Bando ,Japan
Hisanaga, Akito;
Affiliation
Medical Corporation Mitani Family Clinic ,Osaka ,Japan
Mitani, Kazuo;
Affiliation
Akashi Clinic Kanda ,Tokyo ,Japan
Ito, Takashi

The traditional Japanese (Kampo) medicine, kakkonto with shosaikotokakikyosekko, has antiviral and anti-inflammatory effects. In this randomized trial, patients with mild and moderate coronavirus disease (COVID-19) were randomly allocated to the control group receiving conventional treatment for symptom relief such as antipyretics and antitussives or the Kampo group receiving mixed extract granules of kakkonto (2.5 g) and shosaikotokakikyosekko (2.5 g) three times a day for 14 days in addition to conventional treatment. The main outcome was the number of days until total symptom relief. The secondary outcome was the number of days until each symptom’s relief and whether the disease progressed to respiratory failure. We enrolled a total of 161 patients (Kampo group, n = 81; control group, n = 80). The results from Kaplan–Meier estimates of symptom relief showed that there are no significant differences between the groups. However, covariate-adjusted cumulative incidence of fever relief considering competitive risk showed that the recovery was significantly faster in the Kampo group than in the control group (HR 1.76, 95% CI 1.03–3.01). Additionally, the risk of disease progression to moderate COVID-19 requiring oxygen inhalation was lower in the Kampo group than in the control group (Risk Difference −0.13, 95% CI −0.27–0.01). No significant drug-related side effects were observed. Kakkonto with shosaikotokakikyosekko is effective for fever relief with suppression of disease progression in COVID-19 patients. Clinical Trial Registration: https://jrct.niph.go.jp/en-latest-detail/jRCTs021200020 , identifier [jRCTs021200020]

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License Holder: Copyright © 2022 Takayama, Namiki, Arita, Ono, Kikuchi, Ohsawa, Saito, Suzuki, Nakae, Kobayashi, Yoshino, Ishigami, Tanaka, Nochioka, Takagi, Mimura, Yamaguchi, Ishii, Hisanaga, Mitani and Ito.

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