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

Authors
 Sang-Wook Song  ;  Ha-Na Kim  ;  Jae-Yong Shim  ;  Byeong-Yeon Yoo  ;  Dae-Hyun Kim  ;  Sang-Hyun Lee  ;  Joo-Sung Park  ;  Moon-Jong Kim  ;  Jun-Hyun Yoo  ;  BeLong Cho  ;  Hee-Cheol Kang  ;  Kwang-Min Kim  ;  Sung-Soo Kim  ;  Kyung-Soo Kim 
Citation
 Journal of Ginseng Research, Vol.42(4) : 571-576, 2018 
Journal Title
 Journal of Ginseng Research 
ISSN
 1226-8453 
Issue Date
2018
Keywords
Adverse drug reaction ; Adverse event ; Korean Red Ginseng ; Safety ; Tolerability
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.
Files in This Item:
T201806099.pdf Download
DOI
10.1016/j.jgr.2018.07.002
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Family Medicine (가정의학교실) > 1. Journal Papers
Yonsei Authors
Kang, Hee Cheol(강희철) ORCID logo https://orcid.org/0000-0002-0309-7448
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/170881
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