EUCTR2020-002972-11-BE进行中（未招募）1 期
Efficacy of Oscillococcinum® in the treatment of Influenza-like-illness symptoms: a multicentre, randomized, controlled trial in France and Belgium
BOIRO0 个研究点目标入组 800 人开始时间: 2021年8月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
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
- •Aged = 18
- •Patients accepting to participate in the study through signing informed consent;
- •Patients with ILI defined as sudden onset of symptoms and at least one of the following systemic symptoms: fever (=37.8°C) or feverishness (feeling of fever or a chill), malaise headache, myalgia (= 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), less than 24 hours duration.
- •Patients able to take the first dose of study medication in the 24 hours following the first symptoms of ILI
- •Patients agreeing to receive notifications by SMS and/or email to to remind them of the diary completion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Patients refusing to sign the informed consent,
- •Patients with unstable and uncontrolled renal, cardiac, pulmonary, vascular, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), or immunodeficiency disorders, cancer, hepatitis, cirrhosis, asthma or chronic obstructive pulmonary disease (COPD)
- •Participation in a clinical study with an investigational drug within 4 weeks prior to study entry
- •Patients who experienced a previous episode of acute upper respiratory tract infection (URTI), sinusitis, bronchitis, otitis or pneumonia within 4 weeks prior to the Initial Visit
- •Patients taking corticosteroids or immuno-suppressant therapies within 2 months prior to the Initial Visit
- •Patients with evidence/history of alcoholism, drug abuse, psychiatric disorders (including dementia or dementia like syndrome) or any other medical condition that could affect data collection
- •Treatment within 2 weeks prior to the Initial Visit with antiviral drugs such as neuraminidase inhibitors (Tamiflu®, Relenza®, Inavir®), or amantadine (Symmetrel®)
- •Treatment within 1 week prior to Initial Visit with Oscillococcinum® or antibiotics related to respiratory tract infection
- •Treatment within 1 week prior to Initial Visit with antipyretics other than paracetamol, analgesics, decongestants
- •Treatment within 1 week prior to Initial Visit with homeopathic medicine related to ILI at baseline or any other herbal medicine product or dietary supplement known to affect immune and/or inflammatory response
- •Patients with any other disease that requires immediate start of antibiotic treatment related to respiratory tract
- •Pregnant or breast-feeding women
- •Patients with intolerance of fructose, malabsorption of glucose or galactose, sucrase/isomaltase deficit
- •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 electronic diary
- •(For France) Unaffiliated or non-beneficiary of a social security system patient as well as deprived of liberty (article L1121-6 of Code de la Santé Publique) or protected (article L1121-8) adults. (For Belgium) Adult patient deprived of liberty or incapable
研究者
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