CVT-E002 at two 200 mg capsules daily (COLD-FX^®) has been studied in randomized and placebo-controlled clinical trials which have been published in respected peer-reviewed medical and scientific journals.

Early clinical trials of COLD-FX were conducted in groups of high-performance professional athletes. The positive and encouraging results of this and other research led to further clinical research in healthy adults and seniors. The safety and efficacy of COLD-FX has been demonstrated in these trials, allowing this natural health product the comprehensive therapeutic claim “to help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system”.

A Multi-centre Randomized Controlled Clinical Trial of COLD-FX in Healthy Seniors

A randomized, double-blind, placebo-controlled study of CVT-E002 (COLD-FX) [400 mg (standard dose) or 800 mg (high-dose) daily] in 780 immunocompetent community dwelling adults aged 65 years or older who received annual flu immunization, showed that ingestion of COLD-FX over six months reduced the number of Jackson-confirmed upper respiratory infections per person by 36% in the standard dose and 33% in the high dose groups compared to placebo. The difference between the two COLD-FX groups and the placebo group were statistically significant, and the difference between the two COLD-FX groups was not statistically different. COLD-FX was shown to be safe and well-tolerated.
For further information about this study… click here

A Study of Immunological Laboratory Parameters in Human Volunteers

A randomized, double-blind, placebo-controlled trial of CVT-E002 (COLD-FX) (1800, 1200, and 600 mgs per day on three consecutive days) in 50 healthy adults, showed that COLD-FX affects adaptive immunity. Specifically, T-helper lymphocytes were increased in the COLD-FX group compared to placebo after 3 days of treatment. COLD-FX was shown to be safe and well-tolerated.
For further information about this study… click here

A Randomized Controlled Clinical Trial of COLD-FX in Nursing Home Seniors.

Reference: McElhaney, J. et al. 2004. 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 Geriatric Society; 52: 13-19.

In this randomized controlled study, two methods were used to see whether institutionalized seniors contracted upper respiratory infections after daily intake (two 200 mg capsules) of CVT-E002 (COLD-FX):

symptoms alone (one respiratory and one constitutional symptom)
symptoms plus laboratory confirmation of respiratory viral infection

No effect was seen in the incidence of acute respiratory illness as defined by symptoms alone. The authors suggested that the definition for ARI in this study may have been too non-specific resulting in cases that overlapped with allergies or other medical conditions. Using the second, more sensitive method, this study reported that in this group of nursing home seniors (the majority of whom had received the influenza vaccine), there was an 89% relative risk reduction in the incidence of influenza and respiratory syncytial virus infections which had been confirmed through both laboratory testing and clinical symptoms.

This study was a U.S. Phase II authorized trial.

Abstract available via PubMed: click here

A Randomized Controlled Clinical Trial of COLD-FX in the General Population

Reference: Predy, G. et al. 2005. Efficacy Of An Extract On North American Ginseng Containing Poly-Furanosyl-Pyranosyl-Saccharides For Preventing Upper Respiratory Tract Infections: A Randomized Controlled Trial. Canadian Medical Association Journal; 173(9): 1043-1048.

This randomized controlled study investigated the effect of CVT-E002 (COLD-FX) intake (two 200mg capsules daily) for four months in 323 generally healthy adults who suffered at least two upper respiratory infections in the previous year. Statistically significant effects* were shown for both primary (number of colds) and secondary endpoints:

reduced average number of respiratory infections (Jackson-verified) per person by 25%
reduced number of recurrent (two or more) respiratory infections by 56%
reduced severity (total symptom score) by 31%
reduced duration of symptoms by 35%

*relative risk

The Office of Dietary Supplements Division of the National Institutes of Health (NIH) in the U.S. selected this clinical trial for inclusion in its Annual Bibliography of Significant Advances in Dietary Supplements Research. An international team of 50 scientific reviewers chose it as one of 25 selections drawn from more than 1,000 papers published in 58 of the world’s leading peer reviewed medical journals. The NIH, one of the world’s foremost medical research centres and an adjunct of the U.S. Department of Health and Human Services, is considered the steward of medical and behavioral research in the United States.

Abstract available via PubMed: click here

A Randomized and Controlled Trial of COLD-FX in Community-Dwelling Seniors

Reference: McElhaney, J.E. et al. 2006. Efficacy of COLD-FX in the prevention of respiratory symptoms in community dwelling adults: a randomized, double-blind, placebo controlled trial. Journal of Alternative and Complementary Medicine; 12(2): 153-157.

A randomized, double-blind, placebo-controlled study of CVT-E002 (COLD-FX) (two 200 mg capsules daily) in 43 immunocompetent community dwelling of adults aged 65 years or older, showed that ingestion of COLD-FX over four months reduced the relative risk and duration of respiratory symptoms late in the flu season by 48% and 55%, respectively. During the last two months of the trial, significantly fewer subjects in the COLD-FX group (32%) reported respiratory symptoms compared to the placebo group (62%). The duration of symptoms during the last two months was reduced from 12.6 days in the placebo group to 5.6 days in the COLD-FX treatment group. COLD-FX was shown to be safe and well-tolerated.
Abstract available via PubMed: click here

A Study of Immunological Laboratory Parameters in Human Volunteers

Reference: Predy, G. et al. 2006. Immune Modulating Effects of Daily Supplementation of COLD-FX (a Proprietary Extract of North American Ginseng) in Healthy Adults. Journal of Clinical Biochemistry and Nutrition; 39:162-167.

The objective of this study was to examine laboratory parameters in a subset of subjects between 18 and 65 years with a history of more than two colds in the previous year who participated in a randomized double-blind placebo-controlled study. Treatment with CVT-E002 (COLD-FX) (two 200 mg capsules daily for four months) in this group increased the proportion of T-helper and Natural Killer cells and decreased IgA levels in plasma when compared to placebo.

A randomized controlled clinical trial of COLD-FX in children

Reference: Vohra, S. et al. 2008. Safety and Tolerability of North American Ginseng Extract in the Treatment of Pediatric Upper Respiratory Tract Infections : A Phase II Randomized, Controlled Trial of 2 Dosing Schedules. Pediatrics; 122: e402-e410

In this randomized controlled study, the safety and tolerability of two dosing schedules of COLD-FX were demonstrated in a pediatric population (3-12 years). Forty-six children took part in the trial which was based at the University of Alberta. The dosing schedules were based on the participant’s weight and were individually calculated. The standard dose was 26 mg/kg per day on day 1 (maximum: 1800 mg), 17 mg/kg per day on day 2 (maximum: 1200mg), and 9 mg/kg per day on day 3 (maximum 600 mg). The low dose was one half of the standard dose, 13 mg/kg per day on day 1 (maximum of 900 mg), 8.5 mg/kg per day on day 2 (maximum 600 mg) and 4.5 mg/kg per day on day 3 (maximum of 300 mg). Both doses were divided equally to be taken 3 times a day for 3 days and symptoms and adverse events for the following 14 days were compared to the placebo arm. No tolerability problems were reported, the frequency and severity of reported adverse events did not differ between the three arms and no serious adverse events were reported. Total symptom days were reduced in the standard treatment arm compared to both low dose and placebo arms (1.5 vs. 1.9 and 1.9 respectively).
Abstract available via Pediatrics: click here

COLD-FX Doping Control Urinalysis Trial In Athletes

Reference: Goel, D.P. et al. 2004. Doping-control urinalysis of a ginseng extract, Cold-FX, in athletes. International Journal of Sport Nutrition and Exercise Metabolism.; 14(4):473-80.

A doping urinalysis of COLD-FX was conducted under strict ethical and international doping control guidelines in 56 Canadian athletes taking 400 mg daily (two 200 mg capsules daily) for 28 days. The results demonstrated that COLD-FX does not contain or generate banned substances within the body that might create a positive doping control test. COLD-FX was also shown to be safe and well-tolerated.
Abstract available via PubMed: click here

Ongoing Research

Laboratory research on CVT-E002 is being performed by a leading scientist in the Department of Pathology and Molecular Medicine at McMaster University to investigate the precise molecular mechanism of action of CVT-E002. The objective of this research is to further understand how CVT-E002 enhances the immune system. This study is conducted with the support of National Research Council Industrial Research Assistance Program (NRC-IRAP).
For further information about this study... click here

Safety
When considering whether a treatment will be useful, health care professionals perform a "risk-benefit assessment" to put it into appropriate context. In all of the clinical trials conducted on COLD-FX, there have been no differences in reported adverse events between recipients of COLD-FX versus placebo, and other routine medical analyses (blood pressure, blood glucose, etc.) have been normal. Safety and side effects are key components of any medication and COLD-FX has proven to have an excellent safety profile.
For further safety information regarding COLD-FX ... click here

Totality of Evidence
The evidence for the safety and efficacy of COLD-FX includes preclinical and clinical studies published in a number of internationally peer-reviewed scientific and medical journals and dozens of reports at medical and research conferences. As part of the review process to determine the safety and efficacy of a naturally-derived product prior to the issuance of a product license, the regulatory body responsible for natural health products requires the submission of the totality of evidence relevant to a product.

For further information regarding clinical trial results for CVT-E002 (COLD-FX), see the American Botanical Council Therapeutic Monograph and Clinical Monograph for CVT-E002 (COLD-FX)... click here

- The American Botanical Council (ABC), North America's leading nonprofit research and education organization on herbal medicines, has independently produced a Therapeutic Monograph and Clinical Overview for CVT-E002 (COLD-FX), written by Bruce Barrett, MD, PhD and Donald J. Brown, ND. Five independent U.S. physicians and scientists well recognized in the field of natural medicines were involved in the writing and peer review of this scientific report on CVT-E002 (COLD-FX).