Efficacy of Sambucol on the Length of Time to Resolution of Influenza Illness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The length of time to resolution of influenza illness
研究概览
简要总结
The trial will examine the efficacy of sambucol in the treatment of influenza. The primary efficacy endpoint will be the length of time to resolution of influenza illness.The double blind trial will be conducted at the Personnel Clinic, and at the Clinical virology Unit, Hadassah University Hospital, and will include 100 patients with laboratory-confirmed influenza infection, 50 in the sambucol and 50 in the placebo study arm.
详细描述
The trial will be conducted at the Personnel Clinic, and at the Clinical virology Unit, Hadassah University Hospital.
Candidates for participation in the trial :
Patients who will present at the clinic with influenza-like symptoms; men and women ages 20 yrs- 65 yrs who will sign written informed consent
Excluded from the trial will be:
- Pregnant women or women who cannot exclude pregnancy.
- Patients with diabetes.
- Immune-suppressed patients, including patients taking immunosuppressive drugs.
- Patients with renal failure.
- Patients who received the recent influenza vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fever ≥ 380C.
- •The presence of at least one of the following respiratory symptoms: cough, sore throat, nasal congestion/ runny nose.
- •The presence of at least one of the following systemic symptoms: headache, fatigue, myalgia, chills/sweats, malaise.
排除标准
- •Pregnant women or women who cannot exclude pregnancy.
- •Patients with diabetes.
- •Immune-suppressed patients, including patients taking immunosuppressive drugs.
- •Patients with renal failure.
- •Patients who received the recent influenza vaccine.
结局指标
主要结局
The length of time to resolution of influenza illness
次要结局
未报告次要终点
