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

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.