EUCTR2013-001869-16-DE进行中（未招募）不适用
A randomised, multi-centre, parallel group, double-blind, placebo-controlled study to assess the efficacy and safety of Oscillococcinum® in the treatment of symptoms of Influenza-like illness (ILI)
Boiron Laboratoires0 个研究点开始时间: 2013年7月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Aged = 12 and < 65 years of age.
- •2. Patients with ILI defined as sudden onset of symptoms and at least one of the following systemic symptoms: fever (=37.8°C) or chills, headache, myalgia, malaise (= assessment mild, moderate or severe for at least one of these symptoms) and at least one of the following respiratory symptom: cough, sore throat, shortness of breath (= assessment mild, moderate or severe for at least one of these symptoms), of less than or equal to 24 hours duration.
- •3. Patients able to take the first dose of study medication in the first 24 hours of ILI.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 480
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with active and clinically significant renal, cardiac, pulmonary, vascular, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis, cirrhosis, asthma or chronic obstructive pulmonary disease (COPD)
- •2. Participation in a clinical study with an investigational drug within 4 weeks prior to study entry
- •3. Patients who experienced a previous episode of acute upper respiratory tract infection (URTI), sinusitis, bronchitis, otitis or pneumonia within 2 weeks prior to study day 0
- •4. Patients taking steroids or immuno-suppressant therapies within 2 months prior to Study Day 0.
- •5. Participants with evidence/history of alcoholism, drug abuse, psychiatric disorders or any other medical condition that could affect the study completion or the collection of the data relevant for safety or efficacy
- •6. Patients with contraindications for paracetamol, e.g. liver insufficiency, severe renal insufficiency
- •7. Treatment within 2 weeks prior to the Initial Visit with neuraminidase inhibitors, adamantanes or within 1 week with Oscillococcinum® or antibiotics
- •8. Patients with a positive pharyngeal test for Group A streptococcus at inclusion
- •8. Patients with any other disease that requires immediate start of antibiotic treatment.
- •9. Pregnant or breast-feeding women.
- •10. Patients with intolerance of fructose, malabsorption of glucose or galactose, sucrase/isomaltase deficit
- •11. Any other condition which according to the investigator’s judgement is not compatible with the principles of the study, e.g. inability to give informed consent, inability to complete the diary
研究者
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