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Open Access Highly Accessed Study protocol

A placebo-controlled trial of Korean red ginseng extract for preventing Influenza-like illness in healthy adults

Ki-Chan Ha12, Min-Gul Kim1, Mi-Ra Oh1, Eun-Kyung Choi1, Hyang-Im Back12, Sun-Young Kim12, Eun-Ok Park12, Dae-Young Kwon4, Hye-Jeong Yang4, Min-Jeong Kim4, Hee-Joo Kang4, Ju-Hyung Lee5, Kyung-Min Choi6, Soo-Wan Chae12 and Chang-Seop Lee13*

  • * Corresponding author: Chang-Seop Lee lcsmd@jbnu.ac.kr

  • † Equal contributors

Author Affiliations

1 Clinical Trial Center for Functional Foods of Chonbuk National University Hospital, Geumam-dong, Deokjin-gu, Jeonju 561-712, Republic of Korea

2 Department of Medical Nutrition Therapy, Chonbuk National University Medical School, Geumam-dong, Deokjin-gu, Jeonju 561-180, Republic of Korea

3 Department of Internal Medicine, Chonbuk National University Medical School, Geumam-dong, Deokjin-gu, Jeonju 561-180, Republic of Korea

4 Korea Food Research Institute, Baekhyeon-dong, Bundang-gu, Seongnam-City 463-746, Gyeonggi-do, Republic of Korea

5 Department of Preventive Medicine, Chonbuk National University Medical School, Geumam-dong, Deokjin-gu, Jeonju 561-180, Republic of Korea

6 Institute of Jinan Red Ginseng, Banwol-ri, Jinan-gun 657-801, Republic of Korea

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BMC Complementary and Alternative Medicine 2012, 12:10  doi:10.1186/1472-6882-12-10

Published: 8 February 2012

Abstract

Background

Standardized Korean red ginseng extract has become the best-selling influenza-like illness (ILI) remedy in Korea, yet much controversy regarding the efficacy of the Korean red ginseng (KRG) in reducing ILI incidence remains. The aim of the study is to assess the efficacy of the KRG extract on the ILI incidence in healthy adults.

Methods/Design

We will conduct a randomized, double-blind, placebo-controlled study at the onset of the influenza seasons. A total of 100 subjects 30-70 years of age will be recruited from the general populations. The subjects will be instructed to take 9 capsules per day of either the KRG extract or a placebo for a period of 3 months. The primary outcome measure is to assess the frequency of ILI onset in participated subjects. Secondary variable measures will be included severity and duration of ILI symptoms. The ILI symptoms will be scored by subjects using a 4-point scale.

Discussion

This study is a randomized placebo controlled trial to evaluate the efficacy of the KRG extract compared to placebo and will be provided valuable new information about the clinical and physiological effects of the KRG extract on reduction of ILI incidence including flu and upper respiratory tract infections. The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if KRG extract can be shown to be an effective reduction strategy in ILI incidence.

NCT01478009.