[ $\b{S}afety\;\b{A}nd\;\b{E}fficacy$ ] of $\b{K}orean$ red ginseng Intervention (SAEKI) Trial: Rationale, Design, and Expected Findings

  • Sievenpiper John L (Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Clinical Nutrition and Risk Factor Modification Centre) ;
  • Buono Marco Di (Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Clinical Nutrition and Risk Factor Modification Centre) ;
  • Stavro P. Mark (Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Clinical Nutrition and Risk Factor Modification Centre) ;
  • Jenkins Alexandra L (Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Clinical Nutrition and Risk Factor Modification Centre) ;
  • Nam Ki Yeul (Michaels Hospital, Tronto, Korean Ginseng and Tobacco Research Institute) ;
  • Choi Melody (Clinical Nutrition and Risk Factor Modification Centre) ;
  • Naeem Asima (Clinical Nutrition and Rish Factor Modification Centre) ;
  • Leiter Lawrence A (Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Clinical Nutrition and Risk Factor Modification Centre) ;
  • Sung Mi-Kyung (Department of Food and Nutrition, Sookmyung Womens University) ;
  • Vuksan Vladimir (Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Clinical Nutrition and Risk Factor Modification Centre)
  • Published : 2002.10.01

Abstract

Diabetes mellitus is reaching epidemic proportions worldwide. The insufficiency of medication to cope with this burden has coincided with a dramatic rise in the prevalence of use of complementary and alternative therapies, especially herbal treatments. This surge in demand presents a challenge to prove the safety and efficacy of these treatments in diabetes. Korean red ginseng (steam treated Panax ginseng C.A. Meyer) is a strong candidate to succeed. It has been shown to possess a multitude of hypoglycemic effects and improve metabolic disturbances related to diabetes in in vitro and animal models. Data in humans is also emerging to support these benefits. Whether these results can be replicated in a rigorous clinical testing program is unclear. We therefore investigated the antidiabetic effects of Korean red ginseng in a series of 2 acute and 1 longterm randomized, double-blinded, placebo-controlled clinical trials. This paper provides the rationale for this program of study, expanding on the problem of diabetes, its management, and the possible role for Korean red ginseng. It then describes the design and expected findings.

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