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Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial

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Author(s)
Sang-Wook SongHa-Na KimJae-Yong ShimByeong-Yeon YooDae-Hyun KimSang-Hyun LeeJoo-Sung ParkMoon-Jong KimJun-Hyun YooBeLong ChoHee-Cheol KangKwang-Min KimSung-Soo KimKyung-Soo Kim
Keimyung Author(s)
Kim, Dae Hyun
Department
Dept. of Family Medicine (가정의학)
Journal Title
Journal of Ginseng Research
Issued Date
2018
Volume
42
Issue
4
Keyword
Adverse drug reactionAdverse eventKorean Red GinsengSafetyTolerability
Abstract
Background:
Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks.

Methods:
We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit.

Results:
In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group.

Conclusion:
The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.
Keimyung Author(s)(Kor)
김대현
Publisher
School of Medicine (의과대학)
Citation
Sang-Wook Song et al. (2018). Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial. Journal of Ginseng Research, 42(4), 571–576. doi: 10.1016/j.jgr.2018.07.002
Type
Article
ISSN
1226-8453
Source
https://www.sciencedirect.com/science/article/pii/S1226845317303640?via%3Dihub
DOI
10.1016/j.jgr.2018.07.002
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42238
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Family Medicine (가정의학)
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