Efficacy and Safety of COLD-fX in the Prevention of Respiratory Infections in Community-dwelling Seniors: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 780
- 试验地点
- 6
- 主要终点
- To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.
研究概览
简要总结
Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Use of COLD-fX may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.
详细描述
Eligible seniors will be randomly placed into three groups to receive 400 mg/day, 800mg/day or a placebo for a period of six months beginning in October. Daily dosing will be recorded as well as any symptoms not related to having a respiratory infection. For seniors who experience a respiratory infection, they are asked to call a study nurse who will take a nasopharyngeal swab. The seniors are also asked to record on a diary card the severity of their symptoms on a scale from 0-3 (none, mild, moderate, severe). Symptoms include cough, fever, runny nose, stuff nose, aches and pains, headache, chills, sneezing, ear aches and fatigue.The swab will be taken to the lab for testing for upper respiratory viruses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years of age and older
- •current season influenza immunization
- •available for follow-up visits
- •willing and able to sign written informed consent
排除标准
- •HIV infection
- •malignancy (under active observation or treatment)
- •unstable cardiovascular diseases
- •renal abnormalities (serum creatine >200umol/l)
- •pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the last 3 months with oral steroids - prednisone >10mg/day, other chronic respiratory illness)
- •acute or active chronic liver disease
- •neurologic or psychiatric disease (progressive or currently under treatment
- •active tuberculosis
- •multiple sclerosis
- •bleeding disorders
- •planned surgery over the course of the trial
- •on immunosuppressive therapy
- •taking oral steroids at dose = to prednisone 10 mg/day or more
- •taking phenelzine, pentobarbital, haloperidol, warfarin, heparin
- •use of natural health products(except the study product and vitamins and minerals with a dose <600 mg/day of vitamin E and containing no vitamin K) including echinacea or ginseng-containing products (tea, capsules, extracts, tablets)
- •current alcohol/drug abuse
- •major surgery in the past 6 months
- •allergies to ginseng
结局指标
主要结局
To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.
时间窗: During the study time frame of 6 months
次要结局
- To evaluate the effects of the treatment on the incidence and frequency of all respiratory infections meeting the Jackson criteria and to determine the efficacy of COLD-fX supplementation on the severity and duration of symptoms.(six months)