Echinacea for Preventing Colds in Children

紫锥菊预防儿童感冒

• 批准号: 7100444
• 负责人: James A Taylor
• 金额: $ 45.46万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7100444
• 关键词: children; clinical research; placebos

DESCRIPTION (provided by applicant): Upper respiratory tract infections (URIs) are a significant health burden in childhood. The average child suffers 6-8 URIs per year, and up to one-third of these are complicated by secondary bacterial infections. We previously conducted a study to assess the efficacy of Echinacea as a treatment for acute URIs in children. Unfortunately, the results of this study indicate that Echinacea was not significantly superior to placebo in treating URI symptoms in patients 2-11 years old. However, a surprising finding of the project was that children who received Echinacea had fewer subsequent URI than placebo recipients. The proposed project is designed to ascertain if Echinacea is effective in preventing URIs in healthy children, 2-11 years old, and to assess the efficacy and safety of two dosing regimens. Study patients will be randomized to receive standard dose Echinacea 10 days/month for 3 months, high dose Echinacea 10 days/month for three months, or placebo. Respiratory specimens from 100 randomly selected study children with clinical URIs will be assayed for detection of common viral pathogens. Biologic activity of the Echinacea product used in the study will be validated by quantifying increased macrophage activation in vitro. The main study outcomes will be number of clinical URIs during a 120-day observation period, and adverse events. It is postulated the that patients receiving one or more of the Echinacea treatment regimens will have significantly fewer URIs than placebo recipients, and that the use of Echinacea will not lead to significant adverse events. For the proposed project it is anticipated that 660 patients will be enrolled over a 42-month study period.

描述（由申请人提供）：上呼吸道感染（URI）是儿童时期的一个重大健康负担。儿童平均每年遭受6-8次URIs，其中多达三分之一是继发性细菌感染。我们以前进行了一项研究，以评估紫锥菊作为治疗儿童急性URIs的疗效。不幸的是，该研究的结果表明，紫锥菊在治疗2-11岁患者的URI症状方面并不显著优于安慰剂上级。然而，该项目的一个令人惊讶的发现是，接受紫锥菊的儿童比安慰剂接受者的后续URI更少。该项目旨在确定紫锥菊是否能有效预防2-11岁健康儿童的URIs，并评估两种给药方案的有效性和安全性。研究患者将随机接受标准剂量紫锥菊10天/月，持续3个月，高剂量紫锥菊10天/月，持续3个月，或安慰剂。将对100例随机选择的临床URI研究儿童的呼吸道标本进行分析，以检测常见病毒病原体。将通过定量体外增加的巨噬细胞活化来验证研究中使用的紫锥菊产品的生物活性。主要研究结局为120天观察期内的临床URI数量和不良事件。据推测，接受一种或多种紫锥菊治疗方案的患者比安慰剂接受者具有显著更少的URI，并且紫锥菊的使用不会导致显著的不良事件。对于拟定项目，预计将在42个月的研究期内入组660例患者。