Echinacea for Preventing Colds in Children

紫锥菊预防儿童感冒

• 批准号: 7685407
• 负责人: James A Taylor
• 金额: $ 13.01万
• 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 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7685407
• 关键词: 11 year old; Acute; Adverse event; Attention; Bacterial Infections; Biological Assay; Child; Childhood; Clinical; Detection; Dose; Echinacea Preparation; Echinacea purpurea; Enrollment; Health; In Vitro; Incidence; Lead; Macrophage Activation; Morbidity - disease rate; Outcome Study; Patients; Pharmaceutical Preparations; Phytotherapy; Placebos; Preparation; Prevention; Randomized; Randomized Controlled Trials; Recurrence; Safety; Severities; Specimen; Symptoms; Treatment Protocols; Upper Respiratory Infections; Viral; compare effectiveness; design; falls; pathogen; prevent; respiratory

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。儿童平均每年患有 6-8 次上呼吸道感染，其中多达三分之一因继发细菌感染而并发。我们之前进行了一项研究来评估紫锥菊治疗儿童急性上呼吸道感染的疗效。不幸的是，这项研究的结果表明，紫锥菊在治疗 2-11 岁患者的 URI 症状方面并不明显优于安慰剂。然而，该项目的一个令人惊讶的发现是，接受紫锥菊治疗的儿童的后续 URI 比接受安慰剂的儿童要少。拟议项目旨在确定紫锥菊是否能有效预防 2-11 岁健康儿童的 URI，并评估两种给药方案的有效性和安全性。研究患者将被随机分配接受标准剂量紫锥菊，每月 10 天，持续 3 个月，高剂量紫锥菊，每月 10 天，持续三个月，或安慰剂。将对 100 名随机选择的具有临床 URI 的研究儿童的呼吸道标本进行分析，以检测常见的病毒病原体。研究中使用的紫锥菊产品的生物活性将通过量化体外增加的巨噬细胞活化来验证。主要研究结果是 120 天观察期内的临床 URI 数量以及不良事件。据推测，接受一种或多种紫锥菊治疗方案的患者的 URI 明显少于安慰剂接受者，并且使用紫锥菊不会导致重大不良事件。对于拟议项目，预计将在 42 个月的研究期内招募 660 名患者。