The Efficacy and Safety of a Patent Pending Combination of Ginger and Goldenrod Extracts on the Management of Cold Symptoms: A Randomized, Double-Blind Controlled Trial

Johane Guay, Pierre Champagne, Pascal Guibord, Joerg Gruenwald

analyze & realize ag, Berlin, Germany..
Biopharmacopae Inc., Quebec City, Canada.
Institut Privé de Chirurgie, Quebec City, Canada.
Statistician, Lachine, Canada; 4analyze & realize ag, Berlin, Germany..

DOI: 10.4236/fns.2012.312216                

Abstract

Objective: In a randomized, double-blind, exploratory, active-controlled trial, the efficacy and safety of a patent-pending combination of Ginger and Goldenrod extracts (BDI-630) in alleviating cold symptoms in community-dwelling adults was compared to a combination of standardized amounts of Echinacea (EC) components. Methods: 44 healthy adults, experiencing new onset of cold symptoms were randomly assigned to receive either BDI-630 (900 mg) or EC (500 mg) twice daily for 10 days. The severity of cold symptoms and the quality of life was assessed by self-reporting of subjects using the Wisconsin Upper Respiratory Symptom Survey (WURSS-21? 2004). Results: The intent-to-treat population (ITT) consisted of 44 subjects (n = 22 for BDI-630; n = 22 for EC). The modified ITT (mITT) population consisted of 40 subjects, excluding four subjects with major protocol deviations related to inclusion/exclusion criteria and/or use of prohibited drugs from the efficacy analysis (n = 3 for BDI-630 and n = 1 for EC). Results indicated a sig-nificant difference between the two groups: the superiority of BDI-630 over EC was particularly noticeable between Day 1 and Day 7, as demonstrated by a 14-fold difference of the mean percentage of change of total score from baseline in the mITT population. Adverse events (AEs) following the intake of BDI-630 were mostly limited to mild gastrointestinal intolerance in less than 10% of the subjects. Conclusions: BDI-630 was shown to be more effective than EC in alleviating cold symptoms in the adult population, particularly during the first 7 days of treatment. BDI-630 was very well tolerated by all subjects.

Keywords

Randomized Double-Blind Active-Controlled Trial; Common Cold

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	A. M. Fendrick, A. S. Monto, B. Nightengale and M. Sarnes, “The Economic Burden of Non-Influenza-Related Viral Respiratory Tract Infection in the United States,” Archives of Internal Medicine, Vol. 163, No. 4, 2003, pp. 487-494. doi:10.1001/archinte.163.4.487
[2]	P. F. Adams, G. E. Hendershot and M. A. Marano, “Current estimates from the National Health Interview Survey, 1996,” Vital and Health Statistics, Vol. 10, No. 200, 1999, pp. 1-212.
[3]	R. Nahas and A. Balla, “Complementary and Alternative Medicine for Prevention and Treatment of the Common cold,” Canadian Family Physician, Vol. 57, No. 1, 2011, pp. 31-36.
[4]	M. Roxas and J. Jurenka, “Colds and Influenza: A Review of Diagnosis and Conventional, Botanical and Nutritional Considerations,” Alternative Medicine Review, Vol. 12, No. 1, 2007, pp. 25-48.
[5]	R. Rehman, M. Akram, N. Akhtar, et al., “Zingiber Officinale Roscoe (Pharmacological Activity),” Journal of Medicinal Plants Research, Vol. 5, No. 3, 2011, pp. 344-348.
[6]	P. Apáti, K. Szentmihályi, S. T. Kristó, et al., “Herbal Remedies of Solidago Correlation of Phytochemical Characteristics and Antioxidative Properties,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 32, No. 4-5, 2003, pp. 1045-1053. doi:10.1016/S0731-7085(03)00207-3
[7]	B. Barrett, R. L. Brown, M. P. Mundt, et al., “Validation of a Short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21),” Health and Quality of Life Outcomes, Vol. 7, No. 1, 2009, p. 76. doi:10.1186/1477-7525-7-76
[8]	B. Barrett, R. Brown, M. Mundt, et al., “The Wisconsin Upper Respiratory Symptom Survey is Responsive, Reliable, and Valid,” Journal of Clinical Epidemiology, Vol. 58, No. 6, 2005, pp. 609-617. doi:10.1016/j.jclinepi.2004.11.019
[9]	B. Barrett, R. Brown, D. Rakel, et al., “Echinacea for Treating the Common Cold,” Annals of Internal Medicine, Vol. 153, No. 12, 2010, pp. 769-777.
[10]	M. S. Baliga, R. Haniadka, M. M. Pereira, et al., “Update on the Chemopreventative Effects of Subject and Its Phytochemicals,” Critical Reviews in Food Science and Nutrition, Vol. 51, No. 6, 2011, pp. 499-523. doi:10.1080/10408391003698669
[11]	H. Demir, L. Acik, E. B. Bali, et al., “Antioxidant and Antimicrobial Activities of Solidago Virguaurea Extracts,” African Journal of Biotechnology, Vol. 8, No. 2, 2009, pp. 274-279.
[12]	L. Pauling, “Vitamin C, the Common Cold and the Flu,” Penguin Group, New York, 1981.
[13]	L. Kaiser, D. Lew, B. Hirschel, et al., “Effects of Antibiotic Treatment in the Subset of Common-Cold Subjects Who Have Bacteria in Nasopharyngeal Secretions,” The Lancet, Vol. 347, No. 9014, 1996, pp. 1507-1510. doi:10.1016/S0140-6736(96)90670-4
[14]	S. P. Malu, G. O. Obochi, E. N. Tawo and B. E. Nyong, “Antibacterial Activity and Medicinal Properties of Subject (Zingiber Officinale),” Global Journal of Pure and Applied Sciences, Vol. 15, No. 3, 2009, pp. 365-368.
[15]	P. Apáti, P. J. Houghton and A. Kéry, “HPLC Investigation of Antioxidant Components in Solidago Herbal,” Acta pharmaceutica Hungarica, Vol. 74, No. 4, 2004, pp. 223-231.