TY - JOUR
PY - 2019//
TI - Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial
JO - Journal of ginseng research
A1 - Zhang, Li
A1 - Chen, Xiaoyun
A1 - Cheng, Yanqi
A1 - Chen, Qilong
A1 - Tan, Hongsheng
A1 - Son, Dongwook
A1 - Chang, Dongpill
A1 - Bian, Zhaoxiang
A1 - Fang, Hong
A1 - Xu, Hongxi
SP - 676
EP - 683
VL - 43
IS - 4
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" ( in Chinese) because of its "dryness" ( 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.
© 2019 The Korean Society of Ginseng, Published by Elsevier Korea LLC.
Language: en
LA - en SN - 1226-8453 UR - http://dx.doi.org/10.1016/j.jgr.2019.05.006 ID - ref1 ER -