Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial

Abstract

Background: The common cold is the most frequent acute respiratory illness that places a burden on society, both personally and economically. There is no standard therapy; only symptomatic therapy remains the mainstay of common cold treatment. Thus, interest in herbal medicines is on the rise. Eunkyosan and Samsoeum are used for the common cold in East Asian countries. Although Eunkyosan and Samsoeum are clinically used for the treatment of the common cold, their effectiveness and safety have yet to be studied. Therefore, we aimed to evaluate their effectiveness and safety. Methods: This study is a randomized, patient-assessor blind, controlled, parallel, and multicenter clinical trial. A total of 375 participants diagnosed with the common cold will be enrolled via four hospitals. The common cold patients will take a daily dose of Eunkyosan or Samsoeum or a placebo, three times a day for eight days. The primary outcome is the change in total Wisconsin Upper Respiratory Symptom Scale-21-Korean version (WURSS-21-K) score between baseline and six days. The secondary outcome includes the visual analogue scale (VAS). Safety is evaluated and adverse events are assessed throughout the trial. Written informed consent will be obtained from all study participants before enrollment. Discussion: This results will be published in a peer-reviewed journal and disseminated in related conferences. Trial Registration: ClinicalTrials. gov, registration number: NCT04073511. Keywords: Common cold, Herbal medicine, Eunkyosan, Samsoeum