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

AbstractObjectivesWe 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 designThe study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study.ParticipantsPatients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows:Inclusion criteria:Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Clinical stages of mild-to-moderate COVID-19Symptomatic≥ 20 years of ageMale or femaleAbility to communicate in JapaneseOutpatients and inpatientsProvided informed consentExclusion criteria:Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptomsAllergic to Kampo or Western medicines used in this studyPregnant and lactatingUnable to follow upParticipating in another clinical trial or interventional studyHypokalemic or taking oral furosemide or steroidsDetermined unsuitable for this study by the physicianIntervention and comparatorPatients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives fo...
Source: Trials - Category: Research Source Type: clinical trials