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.
RCT Entities:
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.
Authors: Bin Na Hong; Moon Ho Do; You Ri Her; Yeong Ro Lee; Tong Ho Kang Journal: Evid Based Complement Alternat Med Date: 2015-02-01 Impact factor: 2.629
Authors: Bo Cao; Yanfeng Qi; Yan Yang; Xichun Liu; Duo Xu; Wei Guo; Yang Zhan; Zhenggang Xiong; Allen Zhang; Alun R Wang; Xueqi Fu; Haitao Zhang; Lijing Zhao; Jingkai Gu; Yan Dong Journal: PLoS One Date: 2014-11-06 Impact factor: 3.240
Authors: Lei Shen; Si Ra Gwak; Jong Cheon Joo; Bong Keun Song; Seon Woo Cha; Young Uk Song; Mi Kyung Pyo; Soo Jung Park Journal: Evid Based Complement Alternat Med Date: 2020-07-16 Impact factor: 2.629