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Randomized Controlled Trial
. 2012 Nov;18(11):1061-9.
doi: 10.1089/acm.2011.0591. Epub 2012 Aug 21.

Safety and tolerability of Panax ginseng root extract: a randomized, placebo-controlled, clinical trial in healthy Korean volunteers

Nam-Hun Lee  1 , Sa-Ra Yoo, Hyeong-Geug Kim, Jung-Hyo Cho, Chang Gue Son
Affiliations
Randomized Controlled Trial

Safety and tolerability of Panax ginseng root extract: a randomized, placebo-controlled, clinical trial in healthy Korean volunteers

Nam-Hun Lee et al. J Altern Complement Med. 2012 Nov.

Abstract

Objectives: 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.

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Figures

FIG. 1.
FIG. 1.
High-performance thin-layer chromatography (TLC)–based fingerprint of Panax ginseng (PG). Two micrograms of ginsenoside Rg1 (A), 10 μg of ginsenoside Rg3 (B), 150 μg of PG (C), and 300 μg of PG (D) were applied onto prewashed silica gel 60 F254 TLC plates, then separated with mobile phase (chloroform:ethyl acetate:methanol:water [17:46:25:12]). The migrated components were visualized under white light after derivatization with 10% sulfuric acid solution (left), and the densitograms were generated (right). The arrows appeared in the first lane was ginsenoside Rg1 and ginsenoside Rg3 in the second lane.
FIG. 2.
FIG. 2.
Trial flow chart. Primary recruitment identified 252 volunteers. After excluding 60 ineligible persons and 22 subjects declined to participate in this trial, the authors randomly assigned 170 persons to groups as follows: placebo (n=57), Panax ginseng (PG) 500 mg twice a day (BID) (n=56), or PG 1000 mg BID (n=57).
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