Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial
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. Eunky...
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doaj-529336151df4493cba709fd99c0f203b2020-11-25T02:35:17ZengElsevierIntegrative Medicine Research2213-42202020-03-01914853Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trialKwan-Il Kim0Minna Hong1Yang-Chun Park2Beom-Joon Lee3Kitae Kim4Byung Kab Kang5Jun-Yong Choi6Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of KoreaKorean Medicine Hospital of Pusan National University, Yangsan, Republic of KoreaDepartment of Internal Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of KoreaDivision of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of KoreaDepartment of Korean Medicine, Semyung University, Jecheon, Republic of KoreaClinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaKorean Medicine Hospital of Pusan National University, Yangsan, Republic of Korea; School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea; Corresponding author at: School of Korean Medicine, Pusan National University, 49 Busandaehak-ro Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, 50612, Republic of Korea.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, Samsoeumhttp://www.sciencedirect.com/science/article/pii/S2213422020300093 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Kwan-Il Kim Minna Hong Yang-Chun Park Beom-Joon Lee Kitae Kim Byung Kab Kang Jun-Yong Choi |
spellingShingle |
Kwan-Il Kim Minna Hong Yang-Chun Park Beom-Joon Lee Kitae Kim Byung Kab Kang Jun-Yong Choi Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial Integrative Medicine Research |
author_facet |
Kwan-Il Kim Minna Hong Yang-Chun Park Beom-Joon Lee Kitae Kim Byung Kab Kang Jun-Yong Choi |
author_sort |
Kwan-Il Kim |
title |
Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial |
title_short |
Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial |
title_full |
Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial |
title_fullStr |
Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial |
title_full_unstemmed |
Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial |
title_sort |
herbal medicines (eunkyosan and samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial |
publisher |
Elsevier |
series |
Integrative Medicine Research |
issn |
2213-4220 |
publishDate |
2020-03-01 |
description |
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 |
url |
http://www.sciencedirect.com/science/article/pii/S2213422020300093 |
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