EUCTR2020-002972-11-FR进行中（未招募）1 期
Efficacy of Oscillococcinum® in the treatment of Influenza-like-illness symptoms: a national, multicentre, randomized, controlled trial - GOSCI
BOIRO0 个研究点目标入组 800 人开始时间: 2020年9月21日最近更新:
适应症
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), of less than 24h hours duration.
- •- Patients able to take the first dose of study medication within 24 hours following the first symptoms of ILI.
- •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 or 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 the study completion or 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
- •- 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
研究者
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