Journal of Ginseng Research

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

  • Song, Sang-Wook (Department of Family Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Kim, Ha-Na (Department of Family Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Shim, Jae-Yong (Department of Family Medicine, Severance Hospital, Yonsei University College of Medicine) ;
  • Yoo, Byeong-Yeon (Department of Family Medicine, Konyang University Hospital) ;
  • Kim, Dae-Hyun (Department of Family Medicine, Dongsan Hospital, Keimyung University) ;
  • Lee, Sang-Hyun (Department of Family Medicine, National Health Insurance Service Ilsan Hospital) ;
  • Park, Joo-Sung (Department of Family Medicine, Dong-A University Hospital) ;
  • Kim, Moon-Jong (Department of Family Medicine, CHA Bundang Medical Center, CHA Medical University) ;
  • Yoo, Jun-Hyun (Department of Family Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Cho, BeLong (Department of Family Medicine, Seoul National University College of Medicine & Hospital) ;
  • Kang, Hee-Cheol (Department of Family Medicine, Severance Hospital, Yonsei University College of Medicine) ;
  • Kim, Kwang-Min (Department of Family Medicine, Ajou University Hospital, Ajou University School of Medicine) ;
  • Kim, Sung-Soo (Department of Family Medicine, Chungnam National University Hospital) ;
  • Kim, Kyung-Soo (Department of Family Medicine, Seoul St. Mary's hospital, College of Medicine, The Catholic University of Korea)
  • Received : 2017.12.13
  • Accepted : 2018.07.05
  • Published : 2018.10.15
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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.

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