cold-fx griep verkoudheid en voeding


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Cold-FX helpt bij griep en verkoudheid


Heel toevallig stuitte ik op een Amerikaanse firma die natuurgeneesmiddelen
wil ontwikkelen op basis van serieuze onderzoeksmethodes (double blind,
placebo controlled trials). Een produkt van deze firma dat is getest op 679 mensen mbt verkoudheid en griep toont een vermindering van 56% op infecties die hierdoor ontstaan. Is dus de moeite waard om eens naar te
kijken. Ik weet niet of produkt hier al te koop is maar er zal zeker wel een
slimme zakenman wakker worden. Het produkt is gebaseerd op een extract
van de Noord Amerikaanse ginseng (Panax quinquefolium) plant.

Ron


COLD-fX reduces risk of colds, flu and respiratory illness by 89%.

A US FDA authorized randomized double-blind, placebo-controlled trial of COLD-fX (CVT-E002), in institutionalized older adults, demonstrated COLD-fX significantly reduced the risk, by 89%, of developing laboratory confirmed influenza or respiratory syncytial virus (RSV) in a senior population after 8-12 weeks of treatment. At a dose of 400 mg daily (2 X 200 mg), COLD-fX was shown to be safe, well tolerated, and effective for preventing acute respiratory illness due to influenza and RSV. This trial also demonstrated COLD-fX is safe and complimentary to the flu vaccine.

A double-blind, placebo controlled study of COLD-fX in an immunocompetent community dwelling of adults aged 65 years or older demonstrated a statistically significant reduction in the number of illnesses, the majority of which were associated with respiratory symptoms. The significant results included a greater incidence of respiratory symptoms in the placebo group, 76%, versus 45% in COLD-fX group after 4 months of treatment at 400mg (2 X 200mg) daily. COLD-fX was shown to be safe and well tolerated.

References

  1. Gerald N. Predy, Vinti Goel, Ray Lovlin, Allan Donner, Larry Stitt and Tapan K. Basu. Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized controlled trial. Canadian Medical Association Journal, 2005, 173 (9): 1043.

    Abstract not available.

  2. Predy G, Goel V, Lovlin R, and TK Basu. Efficacy of COLD-fX in the prevention of upper respiratory tract infections in healthy adults. CVT Clinical Report 2004.
  3. Wang M, Guilbert LJ, Li J, Wu Y, Pang P, Basu TK, and JJ Shan. A Proprietary Extract from North American Ginseng (Panax Quinquefolium) Enhances IL-2 and IFN-? Productions in Murine Spleen Cells Induced by Con-A, International Immunopharmacology, 2004, 4: 311-315.

    Abstract
    A patented aqueous extract from North American ginseng (Panax quinquefolium), containing mainly oligosaccharides and polysaccharides, is commercially available over the counter as COLD-FX (CVT-E002). This proprietary extract is used for the treatment of upper respiratory tract infections. Its in vitro stimulating effects on the immunoglobulin production by B lymphocytes and on natural immune responses by peritoneal exudates macrophages have been previously reported. Using C57 BL/6 mice, an ex vivo study was conducted to examine Con-A-induced splenocytic productions of interleukin-2 (IL-2) and interferon-gamma (IFN-gamma) as markers of acquired immune responses. CVT-E002 (10-500 microg/ml) significantly increased Con-A-induced IL-2 and IFN-gamma productions in spleen cells in a dose-dependent manner. Such response was seen by the ginseng extract originated from three different lots, suggesting consistency between the lots.

  4. Goel DP, Geiger JD, Shan JJ, Kriellaars D, and GN Pierce. Doping control urinalysis of ginseng extract, COLD-fX, in athletes. International Journal of Sport Nutrition and Exercise Metabolism, 2004, 14(4): 473-80.

    Abstract
    Nutraceuticals may induce doping infractions through contamination of the product itself or their ingestion might be metabolized within the body to create a positive doping control test. We tested this possibility using a commercially available, proprietary ginseng root extract (Cold-FX, CV Technologies Inc., Edmonton, AB). After athletes ingested Cold-FX for 28 d at 400 mg/d, urine samples were collected and processed under strict IOC doping control guidelines and then analyzed for a full screen of IOC banned/restricted substances by an IOC-approved laboratory. There were no positive tests for any banned substances in any of the subjects. Our study demonstrates that ingestion of Cold-FX for 28 d at 400 mg/d does not represent a doping concern for athletes. Carefully controlled clinical studies like this one are necessary to provide the athlete, the nutraceutical industry and IOC regulatory bodies with information to avoid inadvertent exposure to banned/restricted or potentially unhealthy substances.

  5. Deng Y. American ginseng extract, CVT-E002 stimulates macrophages and activated killer cells to secrete interferon-gamma in response to influenza infection. CVT Internal Report.
  6. McElhaney JE, Gravenstein S, Cole SK, Davidson E, O’Neill D, Petitjean S, Rumble B, and JJ Shan. A Placebo-Controlled Trial of a Proprietary Extract of North American Ginseng (CVT-E002) to Prevent Acute Respiratory Illness in Institutionalized Older Adults, Journal of American Geriatrics Society, 2004, 52:13-19.

    Abstract
    OBJECTIVES: To compare a proprietary extract of American ginseng, CVT-E002, with placebo in preventing acute respiratory illness (ARI) in an institutional setting during the influenza season. DESIGN: Two randomized, double-blind, placebo-controlled trials conducted late in the 2000 (8 week) and 2000-2001 (12 week) influenza seasons. SETTING: Long-term care setting that included nursing home and assisted living at three sites. PARTICIPANTS: Eighty-nine (2000) and 109 (2000-2001) enrolled subjects, average age 81 and 83.5, respectively; 74% women. Approximately 90% had received influenza vaccine in each of the 2 years. INTERVENTION: Oral twice-daily administration of a proprietary ginseng extract, CVT-E002, 200 mg or placebo. MEASUREMENTS: ARI was defined as two new respiratory symptoms or one with a constitutional symptom. Confirmation of viral ARI was by culture (influenza or respiratory syncytial virus (RSV)) or serology for influenza. Laboratory safety monitoring was done at 0, 4, and 8 or 12 weeks. RESULTS: An intent-to-treat analysis of pooled data corrected for drug exposure time showed that the incidence of laboratory-confirmed influenza illness (LCII) was greater in placebo- (7 cases/101 subjects) than CVT-E002-treated (1/97) groups (odds ratio (OR)=7.73, P=.033). Combined data for LCII and RSV illness were also greater in placebo- (9/101) than CVT-E002-treated (1/97) groups (OR=10.50, P=.009), for an overall 89% relative risk reduction of ARI in the CVT-E002 group. CONCLUSION: CVT-E002 was shown to be safe, well tolerated, and potentially effective for preventing ARI due to influenza and RSV.

  7. Ueng Y and C Chen. Effects of CVT-E002, a proprietary extract from North American ginseng (Panax quinquefolium) on drug-metabolizing enzymes, Journal of Chinese Medicine 2002, 13: 89-96.

    Abstract CVT-E002, a proprietary extract from North American ginseng (Panax quinquefolium) showed immunomodulating activity. Cytochrome P450 (CYP), UDP-glucuronosyl transferase (UGT), and glutathione S-transferase (GST) are important drug-metabolizing enzymes. Modulation of drug-metabolizing enzymes is a main cause of drug interactions. To assess the possible metabolism-based drug interaction of CVT-E002, effects of CVT-E002 on hepatic CYP, UGT, and GST were studied in C57BL/6J mice. Treatment of mice with 5g/kg/day CVT-E002 for three days had no effects on liver microsomal CYP and cytochrome b3 contents and NADPH-CYP reductase activity. CVT-E002 had no effect on microsomal CYP catalytic activities of the oxidations of 7-ethoxyresorufin, 7-methoxyresorufin, benzo(a)pyrene, 7-ethoxycoumarin, benzphetamine, N-nitrosodimethylamine, erythromycin, and nifedipine in mouse liver. Hepatic microsomal UGT and cytosolic GST activities were not affected by CVT-E002 treatment. These results suggested that CVT-E002 had no effects on hepatic CYP, UGT, and GST activities in mice under this treatment regimen. There might be low potential of incidence of metabolism-based drug interaction by CVT-E002.

  8. Wang M, Guilbert LJ, Ling L, Li J, Wu Y, Xu S, Pang P, and JJ Shan. Immunomodulating Activity of CVT-E002, A Proprietary Extract from North American Ginseng (Panax Quinquefolium), Journal of Pharmacy and Pharmacology, 2001, 53: 1515-1523.

    Abstract
    The activity of CVT-E002, an aqueous extract containing mainly oligosaccharides and polysaccharides from North American ginseng (Panax quinquefolium), as an immunobooster on murine spleen cells and peritoneal macrophages, was studied in-vitro. CVT-E002 stimulated the proliferation of normal mouse spleen cells, of which the major responding subpopulation was identified as B lymphocytes. CVT-E002 also activated peritoneal exudate macrophages leading to enhanced interleukin-1 (IL-1), interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-alpha) and nitric oxide (NO) production. In addition, CVT-E002 stimulated in-vivo immunoglobulin G (IgG) production in treated mice. These results identify some of the immunomodulating activities of CVT-E002 and suggest its use clinically for the modulation of immune responses.

  9. McElhaney JE, and D Reid. Summary of studies with COLD-fX in high performance athletes assessing the tolerability and outcomes related to cold and flu like symptoms. Presented at the First International Scientific congress on Nutrition Athletic Performance, Edmonton, Alberta. August 2001.

    Abstract not available.

  10. Pierce GN, Goel DP, Geiger JD, et al. Doping control urinalysis of ginseng extract, COLD-fX, in Canadian athletes presented at the First International Scientific congress on Nutrition Athletic Performance, Edmonton, Alberta. August 2001.

    Abstract not available.

  11. McElhaney JE, Gravenstein S, Shan JJ, et al. A double-blind, placebo-controlled study of CVT-E002 in immunocompetent, community dwelling adults ages 65 years or older. University of Alberta, Internal Clinical Report, 1999.
  12. ChemBioPrint: The discovery and standardization of beneficial natural health product mixtures. CVT Internal Report.

Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized controlled trial

Gerald N. Predy, Vinti Goel, Ray Lovlin, Allan Donner, Larry Stitt and Tapan K. Basu

Background: Upper respiratory tract infections are a major source of morbidity throughout the world. Extracts of the root of North American ginseng (Panax quinquefolium) have been found to have the potential to modulate both natural and acquired immune responses. We sought to examine the efficacy of an extract of North American ginseng root in preventing colds.

Methods: We conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. A total of 323 subjects 18–65 years of age with a history of at least 2 colds in the previous year were recruited from the general population in Edmonton, Alberta. The participants were instructed to take 2 capsules per day of either the North American ginseng extract or a placebo for a period of 4 months. The primary outcome measure was the number of Jackson-verified colds. Secondary variables measured included symptom severity, total number of days of symptoms and duration of all colds. Cold symptoms were scored by subjects using a 4-point scale.

Results: Subjects who did not start treatment were excluded from the analysis (23 in the ginseng group and 21 in the placebo group), leaving 130 in the ginseng group and 149 in the placebo group. The mean number of colds per person was lower in the ginseng group than in the placebo group (0.68 [standard deviation (SD) 0.82] v. 0.93 [SD 0.91], difference 0.25%, 95% confidence interval [CI] 0.04–0.45). The proportion of subjects with 2 or more Jackson-verified colds during the 4-month period (10.0% v. 22.8%, 12.8% difference, 95% CI 4.3–21.3) was significantly lower in the ginseng group than in the placebo group, as were the total symptom score (77.5 [SD 84.6] v. 112.3 [SD 102.5], difference 1.5%, 95% CI 1.2–2.0) and the total number of days cold symptoms were reported (10.8 [SD 9.7] v. 16.5 [SD 13.8] days, difference 1.6%, 95% CI 1.3–2.0) for all colds.

Interpretation: Ingestion of a poly-furanosyl-pyranosyl-saccharide–rich extract of the roots of North American ginseng in a moderate dose over 4 months reduced the mean number of colds per person, the proportion of subjects who experienced 2 or more colds, the severity of symptoms and the number of days cold symptoms were reported.

Source http://www.cmaj.ca/cgi/content/full/173/9/1043

Persbericht

CV Technologies Inc. (CVT) today reported on clinical trial results of a year-long pivotal study of COLD-fX conducted by a senior Canadian Researcher and Edmonton's Medical Officer of Health which showed that the natural compound cut recurrent colds by more than half.

President, CEO & Chief Scientific Officer, Dr. Jacqueline Shan said, "This trial, which is the first to be completed under Health Canada's new Natural Health Products legislation, displayed impressive results for COLD-fX. It showed that in a group of trial subjects who regularly get at least two colds a year, COLD-fX reduced their chance of getting a second cold by 56%. That will save a lot of people a lot of misery."

Dr. Shan said, "This is a significant scientific and business milestone for CVT. It further confirms that COLD-fX is effective in preventing viral Upper Respiratory Infections including colds and flu in the general population."

The independent double-blind placebo-controlled trial was conducted on the company's behalf by Edmonton's Medical Officer of Health, Dr. Gerry Predy of Capital Health and an associate professor at the University of Alberta, and internationally recognized Nutritional Biochemist Dr. Tapan Basu, a professor at the University of Alberta. Three hundred and twenty-three healthy adults from the general population (18-65 years of age) with a history of at least two upper respiratory infections (colds) in the previous year were recruited for the trial. Each participant was instructed to take two capsules a day of COLD-fX or placebo for a period of 4 months during the winter of 2003/4. (Neither the participants nor the investigators were aware of who was receiving which).

Dr. Basu called the findings, "statistically highly significant". He said "The results are a positive indication that COLD-fX has good potential to minimize incidence of recurrent colds in people who tend to get more than one cold per year."

The results showed a statistically significant reduction (26%) in the average number and frequency of cold infections per person in the COLD-fX group. Even more striking though, was the fact that the data showed that recurrent infections were reduced by 56%, i.e., of those participants reporting one cold infection, the likelihood of (them) contracting additional infections was reduced by more than half. Moreover, of those trial participants taking COLD-fX, there was a 45% reduction in the total number of cold days suffered per participant and a 31% reduction in the severity of their symptoms.

Dr. Predy said, "Our research showed the total number of days with upper respiratory infections per participants for the placebo group was 10.9 days and that was cut to 6.0 days for the people who received COLD-fX. This may give both the public and health care providers further ammunition for preventing and managing viral-induced upper respiratory infections, including the common cold."

In parallel, the ability of COLD-fX to strengthen the immune system was also investigated in this trial. In blood tests of those who were treated with COLD-fX there was a significant increase in the total number of T-lymphocytes and the number of Helper T-lymphocytes, all key in fighting off viral infections. The level of Natural Killer (NK) cells, a critical component of our innate immune system which kills invading viruses, was also significantly increased. These findings confirm earlier clinical and laboratory results showing the efficacy of COLD-fX in preventing respiratory syncytial virus (RSV) and influenza infection and the strengthening of viral-specific killing mechanisms of the immune system.

Dr. Basu said, "This trial was very unique in that it examined a natural compound with the same degree of scientific rigor used for conducting trials of drug candidates in the pharmaceutical industry, a practice that is rarely found in the natural health product (NHP) business." NHP products typically lack proper standardization whereas COLD-fX is standardized through CVT's proprietary ChemBioPrint technology. Dr. Basu said, "COLD-fX was well-tolerated and showed little or no side effects of any kind." He added, "The market is inundated with many NHP preparations making various claims as to their beneficial effect in counteracting colds and flu. COLD-fX is unique in the way that it acts and performs which is confirmed by high-standard clinical trials, such as the current one."

Dr. Shan said, "We are very excited by the promise that these results offer in the search for a cure for the common cold. The efficacy and mechanism of action of COLD-fX demonstrated in these findings may provide some clue as to how to prevent other viral infections  an area warrants further study in a systematic and controlled clinical trial."

Alberta Minister of Economic Development, Mark Norris, said "CV Technologies and its pioneering research are helping to shape Alberta's biotech sector. This emerging sector is important to Alberta's future and furthering its development is critical. I congratulate this industry leader on its success and urge CVT to remain committed to its groundbreaking biotech research."

The study was approved by the Human Research Ethics Board of the Faculty of Agriculture, Forestry and Home Economics of the University of Alberta and the Capital Health/U of A Research Ethics Board. The study was also approved by Health Canada.

Two of the previous six trials done on COLD-fX. were published this year in respected medical journals. COLD-fX is a proprietary natural health compound as a result of 10 years of research and development by 25 scientists at a cost of $15 million. In lab and clinical studies it has been showed to have an excellent safety profile with no adverse effects. COLD-fX is available nationally through leading pharmacies, grocery and health food stores such as Shoppers Drug Mart, Wal-Mart and Costco.

Links:

http://www.ctv.ca/servlet/ArticleNews/

 

 

 


 


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