Kim Kwan-Il, Hong Minna, Park Yang-Chun, Lee Beom-Joon, Kim Kitae, Kang Byung Kab, Choi Jun-Yong
Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, Republic of Korea.
Korean Medicine Hospital of Pusan National University, Republic of Korea.
Integr Med Res. 2020 Mar;9(1):48-53. doi: 10.1016/j.imr.2020.01.009. Epub 2020 Jan 22.
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.
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.
This results will be published in a peer-reviewed journal and disseminated in related conferences.
ClinicalTrials. gov, registration number: NCT04073511.
普通感冒是最常见的急性呼吸道疾病，给个人和社会都带来了负担，包括个人健康和经济方面。目前尚无标准疗法；对症治疗仍是普通感冒治疗的主要手段。因此，对草药的兴趣日益增加。在东亚国家，葛根汤和三物汤被用于治疗普通感冒。尽管葛根汤和三物汤在临床上用于治疗普通感冒，但其有效性和安全性尚未得到研究。因此，我们旨在评估它们的有效性和安全性。
本研究是一项随机、患者和评估者双盲、对照、平行分组的多中心临床试验。将通过四家医院招募总共375名被诊断为普通感冒的参与者。普通感冒患者将每天服用一剂葛根汤或三物汤或安慰剂，一天三次，共八天。主要结局是基线至第6天期间威斯康星上呼吸道症状量表21项韩国版（WURSS - 21 - K）总分的变化。次要结局包括视觉模拟量表（VAS）。在整个试验过程中评估安全性并评估不良事件。在入组前将获得所有研究参与者的书面知情同意书。
本研究结果将发表在同行评审期刊上，并在相关会议上进行传播。
ClinicalTrials.gov，注册号：NCT04073511。
