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
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作者机构：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.
出 版 物：《Food and Nutrition Sciences》 (食品与营养科学（英文）)
年 卷 期：2012年第3卷第12期
页 面：1651-1657页
学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
主 题：Randomized Double-Blind Active-Controlled Trial Common Cold
摘 要：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.
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