Efficacy of Ingesting Gaia Herb's Quick Defense Product in Reducing Acute Respiratory Illness Symptomatology in Women: a 12-Week, Double Blind, Placebo-Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Common cold symptoms
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness of ingesting an alkylamide-rich echinacea root product (Quick Defense, Gaia Herbs) for 2 days immediately following each onset of acute respiratory illness (ARI) symptomatology during a 12-week period in the winter and early spring in women.
Hypothesis: Subjects randomized to Quick Defense compared to placebo over a 12-week period will experience reduced ARI symptomatology, both acutely during each ARI episode and collectively over the entire 12-week study period.
详细描述
The common cold is an acute respiratory illness (ARI) and the most frequent illness people experience, with economic costs estimated at $40 billion per year (Ann Intern Med 2010;153:769-777). Hundreds of different types of viruses cause the common cold, and etiologic agents include rhinovirus, coronavirus, influenza, parainfluenza, respiratory syncytial virus, adenovirus, enterovirus, and metapneumovirus.
The purple coneflower (E. angustifolia and E. purpurea) is one of the most popular herbal supplements in North America and Europe. Echinacea preparations are marketed to provide protection and treatment for the common cold. Reviews and meta-analyses provide modest support for the use of Echinacea in the prevention and treatment of the common cold (Can Fam Physician 2011;57:31-6; Cochrane Database Syst Rev 2006 Jan 25;(1):CD000530; Lancet Infect Dis 2007;7:473-80; Clin Ther. 2006 Feb;28(2):174-83). One meta-analysis concluded that echinacea decreased the odds of developing the common cold by 58% and the duration of a cold by 1.4 days (Lancet Infect Dis 2007;7:473-80).
Echinacea products vary in their composition, due to the use of different species, plant parts, extraction methods, and addition of other components (Planta Med 2008;74:633-7). Some preparations are based on the stabilized fresh juice of aerial parts of E. purpurea, and are rich in hydrophilic derivatives such as polysaccharides and glycoproteins. Other echinacea products come from an extract of root material and contain more lipophilic compounds including N-alkylamides (Ann Intern Med 2010;153:769-777).
Studies indicate that echinacea preparations containing N-alkylamides are bioavailable in humans and can suppress stress-related cellular immune responses (Life Sci 2009;85(3-4):97-106). Echinacea preparations containing N-alkylamides have been linked to multiple immune-modulatory activities including enhanced macrophage phagocytic activity and suppression of the proinflammatory responses of epithelial cells to viruses and bacteria (J Biomed Biotechnol. 2012;2012:769896). Echinacea preparations appear to have low potential to generate cytochrome P450 (CYP 450) drug-herb interactions, and there are no verifiable reports of drug-herb interactions. The estimated risk of taking echinacea products is 1 in 100,000, and thus do not appear to pose a risk to consumers (Mol Nutr Food Res. 2008;52(7):789-98).
Barrett et al. (Ann Intern Med 2010;153:769-777) enrolled subjects within 36 hours of illness onset, and administered echinacea tablets (or placebo) containing 675 mg E. purpurea root standardized to 2.1 mg alkamides and 600 mg E. angustifolia root standardized to 2.1 mg alkamides. Subjects consumed two tablets at enrollment, followed by two-tablet doses three more times within 24 hours of enrollment. Dosing then went to one tablet four times daily for the next four days. Thus, each participant ingested the equivalent of 10.2 g of dried echinacea root during the first 24 hours and the equivalent of 5.1g during each of the next four days. Results were in the direction of benefit, amounting to an average half day reduction in the duration of a week-long cold, or an approximate 10% reduction in overall severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women, ages 18 to 55 years.
- •Non-smokers.
- •Willingness to avoid the use of antibiotics, antivirals, nasal steroids, decongestants, antihistamines, combination cold formulas, echinacea, zinc, or vitamin C during the 12-week study.
- •Willingness to maintain normal dietary and physical activity patterns during the 12-week intervention, and not make formal attempts to lose body weight.
排除标准
- •Current history of autoimmune or immune deficiency disease.
- •History of moderate to severe allergic rhinitis with sneezing or itching of the nose or eyes during the winter/early spring.
- •Current history of asthma with coughing, wheezing, or shortness of breath.
- •Pregnant or planning to be pregnant during the study.
- •History of gastrointestinal upsets, rashes, or allergic reactions to Echinacea.
结局指标
主要结局
Common cold symptoms
时间窗: 12-weeks
The Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess common cold illness severity and symptoms (see attached questionnaire). Subjects will fill in the one-page WURSS-24 at the end of each day during the 12-week monitoring period. This 12-week period will cover the winter and early spring period of 2014. From the responses recorded during the 84-day study, an ARI severity score will be calculated by summing the daily ARI global severity score (0=not sick, 1=very mild ARI to 7=severe). The ARI symptom score for the 84-day period will be calculated by summing all 10 symptom scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). In similar fashion, the ARI function ability score for the 84-day period will be calculated by summing all 9 function scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). Separate scores will be calculated comparing groups for each illness episode recorded by the subjects.
次要结局
未报告次要终点