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Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial

Journal of Ginseng Research 2019년 43권 4호 p.676 ~ 683
 ( Zhang Li ) - Shanghai University of Traditional Chinese Medicine School of Pharmacy

 ( Chen Xiaoyun ) - Shanghai University of Traditional Chinese Medicine Longhua Hospital Department of Rheumatology
 ( Cheng Yanqi ) - Shanghai University of Traditional Chinese Medicine Longhua Hospital Department of Rheumatology
 ( Chen Qilong ) - Shanghai University of Traditional Chinese Medicine Research Center for TCM Complexity System
 ( Tan Hongsheng ) - Shanghai University of Traditional Chinese Medicine School of Pharmacy
 ( Son Dong-Wook ) - Korea Ginseng Corporation
 ( Chang Dong-Pill ) - Korea Ginseng Corporation
 ( Bian Zhaoxiang ) - Hong Kong Baptist University School of Chinese Medicine
 ( Fang Hong ) - Shanghai University of Traditional Chinese Medicine Longhua Hospital Department of Rheumatology
 ( Xu Hongxi ) - Shanghai University of Traditional Chinese Medicine School of Pharmacy

Abstract


Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause “fireness” (上火 in Chinese) because of its “dryness” (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome.

Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale.

Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups.

Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of “fireness” related to KRG.

키워드

Antifatigue effect; Fireness; Korean Red Ginseng; Randomized controlled trial; Safety
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