| |
Shegoi’s™ LarreaRx products contain a patented, highly purified extract of Larrea Tridentata (<pictured), not the crude, unprocessed "chaparral" herb that many other products contain. We employ patented technologies that involve processing of Larrea tridentata extracts with natural, non-toxic antioxidants, such as ascorbic acid (vitamin C), to reduce NDGA quinone and other oxidative compounds than might be present in some other Larrea tridentata extracts. As an additional precaution to further reduce the risk of metabolic conversion of NDGA to NDGA quinone during excretion in vivo, patented and proprietary formulations technologies specify adding additional antioxidant ingredients when formulating dietary supplements containing Larrea Tridentata extract.
In the case of Shegoi’s™ dietary supplement formulation, a five to one ratio of ascorbic acid (vitamin C)! to Larrea extract is used to prepare the finished products. This means that each capsule of dietary supplement contains 50 milligrams of proprietary Larrea extract and 250 milligrams of ascorbic acid (vitamin C). The use of ascorbic acid and/or other antioxidants to suppress the formation of quinone metabolites in vivo is well documented in pharmacology literature.
Formulations of Shegoi's™ patented Larrea extract were the subject of an independent scientific study conducted at the University of Arizona College of Medicine. This data shows that Larrea extract produced according to the patented processing methods is no more toxic to liver tissue than other generally recognized as safe (GRAS) food substances such as cinnamon oil and clove oil. Additionally, when the patented extract is formulated with a five-fold excess of ascorbic acid as is done in Shegoi’s ™ dietary supplement products, this mixture of Larrea extract and ascorbic acid in a 5:1 ratio is substantially safer than cinnamon oil or clove oil. The results from this independent study, using a very advanced hepatotoxicity model, clearly show that Larrea processed and formulated according to Shegoi's™ patented technology is extremely safe.
In Fall 2003, as part of an ongoing research and development program, Shegoi’s™ contracted an additional toxicology safety study through a third-party clinical research organization. This study, compliant with the principles of the Good Laboratory Practice Regulations of the United States Food and Drug Administration, was designed to include a detailed pathologic histology of the excretory system organs, the liver and the kidneys, in addition to addressing systemic toxicity. The study was commissioned through The American Institute for Biosocial and Medical Research, Inc. (Tacoma, WA), a leading consultant for natural and medicinal products research and conducted at Pharmaceutical Control and Development Laboratory Co. Ltd. This study further confirms the safety of Shegoi's™ oral dietary supplement formulation. The summary of the 32 page report concludes that "no adverse effects (toxic symptoms, illness, deaths, weight changes or toxic gross pathological changes) were noted during the 14 day examination period following a 2,000 milligram/kilogram dose of the (dietary supplement formulation containing proprietary Larrea extract and ascorbic acid in a 1:5 ratio in excipient base)." The 2,000 milligram/kilogram dose is "the highest dose which can be given to rats safely and this is the limit dose suggested in the international guidelines for acute toxicity testing". This excessive dose used for testing purposes is roughly the equivalent of a 150 pound man (68 kilograms) consuming over 270 capsules of dietary supplement (over 135 times the maximum recommended daily amount).
• Larrea Tridentata has been safely used as a plant medicine by for centuries by both Native Americans and folk medical practitioners. Larrea has seen an increasing re-surgence in use by naturopathic physicians and practitioners of complementary medicine for treating a wide variety of inflammatory and infectious disorders.
• Larrea Tridentata is an official homeopathic drug in the United States and Europe and has a decades-long history of safe use as such. Homeopathic Larrea preparations are commonly formulated at a similar concentration to that present in the oral dietary supplement product.
• In the July 2001 issue of the Journal of Alternative and Complementary Medicine, an article entitled, " The safety of low-dose Larrea tridentata (DC) Coville (creosote bush or chaparral): a retrospective clinical study ", attests to the safety of reasonable oral doses of Larrea as an herbal remedy.
As an additional measure of safety and to comply with the recommendations of the American Herbal Products Association (AHPA) regarding ingested products containing Larrea tridentata , Shegoi™ has voluntarily included the following precautionary wording which is prominently displayed on the label of oral dietary supplements containing Larrea tridentata extract, "Seek advice from a health care practitioner before use if you have had or may have had liver disease. Discontinue use if any unusual symptoms such as nausea, fever, fatigue, abdominal pain or jaundice (e.g. dark urine, yellow discoloration of the eyes or skin) should occur". The officers of Shegoi™ feel that inclusion of this precautionary wording on the product label, while possibly diminishing sales of dietary supplement products, is a very reasonable measure that, combined with all the other safety measures undertaken, makes for a very safe product line.
|