Safety and Toxicological Evaluation of VENETRON®
\A Botanical Health Product\

VENETRON® is a commercial botanical product made from the leaves of Apocynum venetum L. It contains flavonoids, with the main functional components being hyperoside and isoquercitrin. The safety of VENETRON® were evaluated in animals and human clinical trials. Briefly, the 50 lethal dose of VENETRON® was determined to be greater than 2000 mg/kg body weight in an acute oral toxicity study of mice. An 8-week subchronic toxicity study in rats revealed the no-observed-adverse-effect-level for VENETRON® to be at least 250 mg/kg body weight/day. Drug interaction testing indicated that VENETRON® did not influence cytochrome P450 3A or P-glycoprotein in rats. Furthermore, 30 healthy volunteers in Japan participated in a safety study, ingesting 50 mg/day for weeks 1-8, followed by 150 mg/day for weeks 9-12. No adverse effects resulted from taking VENETRON®, and biochemical parameters remained within the reference ranges. Also through a placebo-controlled study with 17 healthy volunteers in Japan, ingesting 50 mg/day for 8 days, showed no adverse effects from taking VENETRON®. In addition, an 8-week study of 50 mg VENETRON®/day was also conducted in 39 individuals in Canada, the UK, and the USA. The adverse events and blood pressure records indicated no difference between the VENETRON® and placebo groups. These results demonstrate the safety of VENETRON® and provide overall support for the potential of VENETRON® in various health-related applications.