Safety and Tolerability of Panax ginseng Root Extract: A Randomized, Placebo-Controlled, Clinical Trial in Healthy Korean Volunteers
Safety and Tolerability of Panax ginseng Root Extract: A Randomized, Placebo-Controlled, Clinical Trial in Healthy Korean Volunteers
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DOI：
10.1089/acm.2011.0591
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发表时间：
2012-11-01
影响因子：
2.6
通讯作者：
Son, Chang Gue
中科院分区：
文献类型：
--
作者：
Lee, Nam-Hun;Yoo, Sa-Ra;Son, Chang Gue
目的：人参被广泛用作适应原，是过去十年美国十大畅销草药补充剂之一。然而，很少有关于人参在人体研究中的毒性的报道。由于缺乏毒理学研究，在人类，这项研究调查是否P.人参管理引起任何明显的毒性作用在健康volunteers.Methods：这项研究的目的是作为一个随机，双盲，安慰剂对照，平行组试验在健康志愿者。要求受试者在筛选时通过体格检查、病史和实验室（血液学和生化）检查评估为健康、无任何重大疾病。合格的受试者接受人参提取物（1克/天或2克/天）或安慰剂超过4周periods.Results：虽然轻微的不良事件，如消化不良，潮热，失眠，便秘，在人参和安慰剂组，没有严重的不良反应，人参管理报告。在血液学和生化tests.Conclusions：P.人参给药4周被证明是安全的，耐受性好，没有任何不良的毒性作用，在健康的男性和女性志愿者。正在进行的多中心合作努力的未来结果，以评估人参的短期和长期影响，可能有助于我们目前对这种草药产品的安全性和耐受性的理解。
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.