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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-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage: a structured summary of a study protocol for a randomized controlled trial.

Shin TakayamaTakao NamikiTakashi ItoRyutaro AritaHajime NakaeSeiichi KobayashiTetsuhiro YoshinoTomoaki IshigamiKoichiro TanakaMosaburo KainumaKotaro NochiokaAiri TakagiMasaru MimuraTakuhiro YamaguchiTadashi Ishii
Published in: Trials (2020)
Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Keyphrases
  • randomized controlled trial
  • clinical trial
  • study protocol
  • sars cov
  • early onset
  • systematic review
  • phase ii
  • double blind