Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial

Kwan-Il Kim; Minna Hong; Yang-Chun Park; Beom-Joon Lee; Kitae Kim; Byoung Kab Kang; Jun-Yong Choi

doi:10.1016/j.imr.2023.101005

Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial

Integr Med Res. 2023 Dec;12(4):101005. doi: 10.1016/j.imr.2023.101005. Epub 2023 Oct 26.

Authors

Kwan-Il Kim^{1

2}, Minna Hong^{3

4}, Yang-Chun Park⁵, Beom-Joon Lee^{1

2}, Kitae Kim⁶, Byoung Kab Kang⁷, Jun-Yong Choi^{3

4

8}

Affiliations

¹ Department of Clinical Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
² Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine Kyung Hee University, Kyung Hee University Medical Center, Seoul, South Korea.
³ Department of Korean Medicine, The Graduate School, Pusan National University, Yangsan, South Korea.
⁴ Department of Korean Internal Medicine, Korean Medicine Hospital of Pusan National University, South Korea.
⁵ Department of Internal Medicine, College of Korean Medicine, Daejeon University, Daejeon, South Korea.
⁶ Department of Korean Medicine, Semyung University, South Korea.
⁷ Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, South Korea.
⁸ School of Korean Medicine, Pusan National University, Yangsan, South Korea.

Abstract

Background: Eunkyosan (EKS) and Samsoeum (SSE), which are called Yin qiao san and Shen su yin in Chinese, are commonly used herbal medicines for the common cold in East Asian countries. This study aimed to evaluate the effectiveness and safety of EKS and SSE for treating the common cold.

Methods: A randomized, patient-assessor-blind, placebo-controlled, parallel, and multicenter clinical trial was conducted. Adult participants who had one or more cold within 48 h before screening, were randomly allocated to EKS, SSE, or placebo groups. The recruitment goal was planned to be 375 participants. They took an EKS, SSE, or placebo, thrice daily for up to 8 days. The primary outcome was the change in the total score of the Wisconsin Upper Respiratory Symptom Scale-21-Korean version (WURSS-21-K) on day 6 compared to the baseline. The secondary outcomes included visual analog scale (VAS) scores and the duration of symptoms was assessed throughout the trial.

Results: A total of 128 participants were enrolled and 44, 42, and 42 were allocated to the EKS, SSE, and placebo groups, respectively. This study was prematurely terminated due to the COVID-19 pandemic, and we were unable to recruit all the planned participants (n = 375). EKS showed significant clinical effectiveness over the placebo group in the treatment of the common cold, as assessed by the total, symptom, and quality of life scores of WURSS-21-K and VAS, whereas SSE showed significant improvement over the placebo group in terms of WURSS-21-K symptom score. No severe adverse events were reported.

Conclusions: Although EKS and SSE demonstrated statistically significant clinical effectiveness and safety in patients with the common cold, we failed to recruit our pre-planned number of participants. Future definitive full-scale studies are needed to confirm these results.

Trial registration: ClinicalTrials. gov, registration number: NCT04073511. Registered on 29 August 2019.

Keywords: Common cold; Eunkyosan (Yin Qiao San); Herbal medicine; Samsoeum (Shen Su Yin).

Associated data

ClinicalTrials.gov/NCT04073511