TY - JOUR
T1 - Safety and antifatigue effect of Korean Red Ginseng
T2 - a randomized, double-blind, and placebo-controlled clinical trial
AU - Zhang, Li
AU - Chen, Xiaoyun
AU - Cheng, Yanqi
AU - Chen, Qilong
AU - Tan, Hongsheng
AU - Son, Dongwook
AU - Chang, Dongpill
AU - Bian, Zhaoxiang
AU - Fang, Hong
AU - Xu, Hongxi
N1 - Funding Information:
This study was supported by the 2017 grant from the Korean Society of Ginseng , the National Natural Science Foundation of China (NSFC) grant No. 81603344 , the Three-year development plan project for Traditional Chinese Medicine (Grant No. ZY2018-2020-CCCX-2001-02 ) and Xinglin Yong Talent Program (Dr. Li Zhang).
PY - 2019/10
Y1 - 2019/10
N2 - 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.
AB - 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.
KW - Antifatigue effect
KW - Fireness
KW - Korean Red Ginseng
KW - Randomized controlled trial
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85067187881&partnerID=8YFLogxK
U2 - 10.1016/j.jgr.2019.05.006
DO - 10.1016/j.jgr.2019.05.006
M3 - Journal article
AN - SCOPUS:85067187881
SN - 1226-8453
VL - 43
SP - 676
EP - 683
JO - Journal of Ginseng Research
JF - Journal of Ginseng Research
IS - 4
ER -