Safety and tolerability of Panax ginseng root extract: a randomized, placebo-controlled, clinical trial in healthy Korean volunteers.
OBJECTIVE
Panax ginseng has been extensively used as an adaptogen and is among the top 10 selling herbal supplements in the United States over the past decade. However, there have been few reports about the toxicity of P. ginseng in human studies. Given the lack of toxicological studies in human, this study investigated whether P. ginseng administration causes any noticeable toxic effects in healthy volunteers.


METHODS
This study was designed as a randomized, double-blind, placebo-controlled, and parallel group trial in healthy volunteers. The subjects were required to be healthy, free from any significant disease, as assessed at screening by physical examination, medical history, and laboratory (hematological and biochemical) tests. Eligible subjects received P. ginseng extract (1 g/day or 2 g/day) or placebo over a 4-week period.


RESULTS
Although mild adverse events, such as dyspepsia, hot flash, insomnia, and constipation, were reported in both P. ginseng and placebo group, no serious untoward reactions were reported following P. ginseng administration. Nonsignificant changes were observed in hematological and biochemical tests.


CONCLUSIONS
P. ginseng administration for 4 weeks was shown to be safe, tolerable, and free of any untoward toxic effect in healthy male and female volunteers. Future results from ongoing multicenter collaborative efforts to evaluate short- and long-term effects of P. ginseng may contribute to our current understanding of safety and tolerability of this herbal product.
Liver and Immunology Research Center, Daejeon Oriental Hospital of Oriental Medical College of Daejeon University, Daejeon, Republic of Korea.
Nam-Hun
NH
Lee
Sa-Ra
SR
Yoo
Hyeong-Geug
HG
Kim
Jung-Hyo
JH
Cho
Chang Gue
CG
Son
D000293:Adolescent; D000328:Adult; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology; D019584:Hot Flashes / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D005894:Panax / Q000633:toxicity*; D008517:Phytotherapy; D010936:Plant Extracts / Q000494:pharmacology / Q000633:toxicity*; D018517:Plant Roots; D012016:Reference Values; D056910:Republic of Korea; D007319:Sleep Initiation and Maintenance Disorders / Q000209:etiology; D055815:Young Adult
D010936:Plant Extracts