1. Ingredients: What is COLD-FX?
COLD-FX is a highly purified ChemBioPrint product derived from the roots of North American ginseng (Panax quinquefolius). Each capsule contains 200 mg of, CVT-E002, a unique extract of polysaccharides that has been shown in laboratory and clinical studies to strengthen the immune system. Through Afexa Life Sciences’ proprietary process, COLD-FX undergoes vigorous testing to ensure that every batch has consistent chemical identity and biological activity.
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2. What is ChemBioPrint (CBP)?
ChemBioPrint stands for Chemical Biological FingerPrinting, proprietary standardization technology used to ensure the quality of all ChemBioPrint products. In the case of COLD-FX, Chemical FingerPrinting identifies a "print" of the active chemical components that strengthen the immune system. Biological FingerPrinting identifies the effect of the extract on the immune system through a series of laboratory evaluations. As a result of Afexa Life Sciences' proprietary technology, COLD-FX undergoes vigorous testing to ensure that every batch has consistent chemical identity and biological activity.
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3. How is COLD-FX different from other ginseng products?
Most ginseng products on the market are Asian ginseng (Panax ginseng). COLD-FX is a highly purified extract derived from North American ginseng (Panax quinquefolius) which has a very different chemical and biological profile than Asian ginseng. Because COLD-FX is comprised of specific active viral-targeted, immune-enhancing molecules, polysaccharides, it doesn't exhibit the other effects typically associated with ginseng products such as enhanced vitality, mental alertness and mood improvements. In addition, although COLD-FX is an extract of North American ginseng, its highly purified and precise chemical composition makes comparison with "ginseng" in general, inappropriate. Comparing COLD-FX with raw ginseng roots is like comparing acetylsalicylic acid (the active ingredient in Aspirin) with willow tree bark (the source material of acetylsalicylic acid).
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4. What is COLD-FX intended for?
COLD-FX is your daily defence against colds and flu. It has been approved to help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.
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5. How does it work?
A number of studies, including both experimental and clinical, have shown that COLD-FX stimulates the immune system. These effects were found on both the innate and the acquired immune system and both cell-mediated and humoral (antibody)-mediated immunity have been shown to be enhanced.
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6. What evidence do you have to support its efficacy and safety?
To date, 7 clinical trials involving a diverse population of up to 679 subjects, have been carried out on COLD-FX. In these trials, COLD-FX has been found to be highly effective in reducing the frequency, severity and duration of cold and flu symptoms. It was also found to be safe and well-tolerated. For more information click here.
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7. What dosage of COLD-FX should I take?
COLD-FX has been shown effective at 1 capsule twice daily to maintain an optimal immune system.
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8. What is the difference between COLD-FX and COLD-FX Extra Strength?
COLD-FX is to be used daily whereas COLD-FX Extra Strength is a higher dosage intended to be used short-term at the first sign of cold or flu symptoms.
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9. What is the difference between COLD-FX and the product previously marketed for daily use?
There is no difference. Each capsule of COLD-FX consists of 200 mg of CVT-E002 a unique extract derived from North American ginseng and is recommended at 1 capsule twice daily.
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10. Are there any side effects associated with COLD-FX?
No side effects are observed in laboratory studies when given at 500 times higher than the recommended dose at 1 time and 25 times higher than the recommended dose for 30 days. In clinical studies, side effects have also not been associated with the recommended dosing regimen. Although there are no known interactions with herbs, drugs or medical conditions, individuals with serious medical conditions or taking medications should consult a health care practitioner before taking COLD-FX.
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11. Will COLD-FX overstimulate my immune system?
Laboratory studies have indicated that COLD-FX does not overstimulate the immune system, but rather induces more moderate changes which reflect healthy levels of immune system components such as cytokines and Natural Killer (NK) cells. Clinical studies have also demonstrated that COLD-FX consumption is not associated with overstimulation of the immune system.
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12. What about interactions with other drugs such as NSAIDs, antibiotics, lipid-lowering medications, oral contraceptives, blood pressure medications, antidepressants, beta blockers and synthroid?
There are no known interactions of COLD-FX with other medications. Laboratory studies have demonstrated no effect of COLD-FX on the major drug-metabolizing enzymes of the liver. Additionally, the active ingredients of COLD-FX, polysaccharides, are very large molecules. This means they are unlikely to enter the bloodstream and instead exert immune-stimulating effects in the gastrointestinal tract, although this remains to be confirmed in scientific studies. Thus, COLD-FX is thought to exhibit a low likelihood of interaction with other drugs. However, since specific clinical trials have not been conducted to investigate interactions with other medications consult a health care practitioner before using COLD-FX.
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13. I have an autoimmune disorder. Would it be safe for me to take COLD-FX?
COLD-FX has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in populations with autoimmune diseases. Individuals with arthritis were permitted to participate in our US-regulated trials in seniors and the frequency of adverse events was not different in the COLD-FX versus the placebo (control) group. For other more serious autoimmune conditions such as lupus and multiple sclerosis, we recommend consulting a health care practitioner before taking COLD-FX. Our laboratory studies suggest that COLD-FX is unlikely to interact with other medications, including drugs used to treat autoimmune conditions, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX.
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14. I have diabetes. Would it be safe for me to take COLD-FX?
COLD-FX has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in diabetic populations. Individuals with diabetes were permitted to participate in our US-regulated trials in seniors; blood glucose was not affected by COLD-FX intake and the frequency of adverse events was not different in the COLD-FX versus the placebo (control) group. However, to ensure that COLD-FX is safe to consume in your specific situation, we recommend consulting a health care practitioner and monitoring of general health and glucose levels when taking COLD-FX. Our laboratory studies suggest that COLD-FX is unlikely to interact with other medications, including anti-diabetic drugs, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX.
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15. I have high blood pressure. Would it be safe for me to take COLD-FX?
COLD-FX has been demonstrated safe and effective in healthy individuals. Clinical trials have not been conducted specifically in populations with high blood pressure. Individuals with high blood pressure were permitted to participate in our US-regulated trials in seniors; although blood pressure was not specifically assessed, there were no adverse events related to blood pressure regulation and COLD-FX intake. However, to ensure that COLD-FX is safe to consume in your specific situation, we recommend consulting a health care practitioner and monitoring of general health and blood pressure when taking COLD-FX. Our laboratory studies suggest that COLD-FX is unlikely to interact with other medications, including antihypertensive drugs, but to be safe, please speak to a health care practitioner if you are taking these medications before consuming COLD-FX.
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16. I am on blood thinners and I have been advised not to take ginseng products. Would it be safe for me to take COLD-FX?
High doses of some forms of ginseng which are high in ginsenosides have been shown to affect the metabolism and effect of blood thinners such as warfarin. Although COLD-FX is composed of molecules, polysaccharides, which are not thought to cause drug interactions, and laboratory and clinical studies have indicated that the likelihood of drug interaction with COLD-FX is greatly reduced, to be safe, individuals taking blood thinners thinners should avoid the use of COLD-FX.
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17. Someone mentioned to me that taking COLD-FX might be dangerous for women who have or are at risk for developing cancer and that it "feeds" hormonal cancers. Is this correct?
No, this is not correct. COLD-FX has been clinically proven to be a safe and effective product. The safety of COLD-FX has been reviewed by both Health Canada and the U.S. FDA who filed a safety-related New Dietary Ingredient submission without comment. There is no evidence suggesting that COLD-FX is unsafe for patients with cancer, or specifically, hormone-related cancers. COLD-FX has not demonstrated any carcinogenic effects in toxicity studies in any of the clinical trials or through the extensive usage by the general population.
This false impression may relate to some un-confirmed laboratory studies suggesting that crude ginseng containing chemicals known as ginsenosides may have estrogen-related effects. During the COLD-FX manufacturing process, these ginsenosides are removed so that the final product is comprised of a proven safe ingredient: polysaccharides (specifically, poly-furanosyl-pyranosyl-saccharides).
There is no clinical evidence to suggest that ginseng in general is unsafe for women who have or are at risk for developing hormone-related cancers. In fact, a recent study published in the American Journal of Epidemiology, February 16, 2006 (Cui Y et al, 163(7):645) demonstrated that regular users of ginseng had improved survival and quality of life in breast cancer patients. A well-controlled Mayo Clinic study sponsored by the National Cancer Institute of the U.S. NIH, further investigated the potential benefits of American ginseng in cancer patients, including women. On June 3, 2007, the results of this rigorous pilot study were presented. Researchers found that a form of American ginseng provides greater improvements in fatigue and vitality in patients who received the highest doses tested, compared to lower doses or no treatment.The treatment also appeared to be safe and well tolerated (no statistically significant differences in various safety parameters between each of the study groups). COLD-FX has also demonstrated anti-cancer effects through immune enhancement in pre-clinical laboratory studies of a leukemia model.
Although there is no evidence to suggest COLD-FX is un-safe for women who have or are at risk for developing hormone-related cancers, it is recommend that individuals with any serious medical condition consult with their health care practitioner prior to taking COLD-FX.
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18. Can I take COLD-FX if I am pregnant or nursing?
Clinical studies have not been conducted on the use of COLD-FX during pregnancy or nursing. Therefore do not use product if pregnant or nursing.
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19. Is COLD-FX recommended for children under the age of 12?
Studies have not been conducted to assess the efficacy or safety of COLD-FX among children under the age of 12 and therefore we do not recommend the use of this product for children in this age group.
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