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

Abstract

BackgroundKorean 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.MethodsWe 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.ResultsIn 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.ConclusionThe present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

Immuno-enhancement effects of Korean Red Ginseng in healthy adults: a randomized, double-blind, placebo-controlled trial

“…Recently, a KRG intake safety study was conducted in 1,000 healthy adult subjects. The results showed that KRG tablets are safe when consumed 2 g a day for 24 weeks [ 54 ]. In the present clinical study, there were no clinically significant adverse reactions due to the administration of KRG, and there were no clinically significant results in other safety evaluation factors.…”

Herbal Medicine for Cardiovascular Diseases: Efficacy, Mechanisms, and Safety

“…Recently, Song et al performed a large-scale clinical study with 1000 participants randomly divided into two groups; a placebo and a group supplemented with 2 g/d of KRG. Their findings asserted the safety and tolerability of KRG (Song et al, 2018).…”

The Effect of Korean Red Ginseng on Symptoms and Inflammation in Patients With Allergic Rhinitis

“…No serious side effects were observed, and 2 mg/d of KRG for 24 weeks was shown to be safe and tolerable for healthy adults. 31 In previous study, the interaction of KRG with major cytochrome P450 (CYP) enzymes and drug transporter P-glycoprotein (P-gp) was observed after administration of CYP substrate drugs (caffeine, losartan, dextromethorphan, omeprazole, midazolam, and fexofenadine) in healthy adult. Korean red ginseng did not interact with CYP enzymes or P-gp.…”