A multi-center, randomized controlled trial by the Integrative Management in Japan for Epidemic Disease (IMJEDI study-RC
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LETTER
Open Access
A multi-center, randomized controlled trial by the Integrative Management in Japan for Epidemic Disease (IMJEDI study-RCT) on the use of Kampo medicine, kakkonto with shosaikotokakikyosekko, in mild-tomoderate COVID-19 patients for symptomatic relief and prevention of severe stage: a structured summary of a study protocol for a randomized controlled trial Shin Takayama1,2,3* , Takao Namiki4, Takashi Ito5, Ryutaro Arita1,2, Hajime Nakae6, Seiichi Kobayashi7, Tetsuhiro Yoshino8, Tomoaki Ishigami9, Koichiro Tanaka10, Mosaburo Kainuma11, Kotaro Nochioka12, Airi Takagi13, Masaru Mimura14, Takuhiro Yamaguchi15 and Tadashi Ishii1,2,3
Abstract Objectives: We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment. Trial design: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigatorsponsored, two-arm study. (Continued on next page)
* Correspondence: [email protected] 1 Department of Kampo Medicine, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan 2 Department of Education and Support for Regional Medicine, Tohoku University Hospital, 1-1, Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Takayama et al. Trials
(2020) 21:827
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Participants: Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. 2. 3. 4. 5. 6. 7. 8.
Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Clinical
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