CTRI/2021/02/031250已完成4 期
A Prospective, multicenter, randomised, placebo controlled clinical study to evaluate efficacy of Oscillococcinum�® in the treatment of Influenza-like-illness symptoms. - OSCIINDIA
Boiron Laboratoires0 个研究点目标入组 755 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 755
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Aged 6 years to 12 years for Paediatrics population or Aged 18 years up to 65 years for adult population
- •2.Patients or parents of patients accepting to participate in the study through signing informed consent
- •3.Patients with ILI defined as sudden onset of symptoms and at least one of the following systemic symptoms fever (ââ?°Â¥37.8Ã?°C)/ 100.04Ã?° F 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.
- •4.Patients able to take the first dose of study medication in the 24 hours following the first symptoms of ILI.
排除标准
- •1.Patients and parents refusing to sign the informed consent
- •2.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)
- •3.Participation in a clinical study with an investigational drug within 4 weeks prior to study entry
- •4.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
- •5.Patients taking corticosteroids or immuno-suppressant therapies within 2 months prior to the Initial Visit
- •6.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
- •7.Treatment within 2 weeks prior to the Initial Visit with antiviral drugs such as neuraminidase inhibitors (Oseltamivir, zanamivir, laninamivir octanoate), or amantadine
- •8.Treatment within 1 week prior to Initial Visit with Oscillococcinum or antibiotics related to respiratory tract infection
- •9.Treatment within 1 week prior to Initial Visit with antipyretics other than paracetamol, analgesics, decongestants
- •10.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
- •11.Patients with any other disease that requires immediate start of antibiotic treatment related to respiratory tract
- •12.Pregnant or breast-feeding women
- •13.Patients with intolerance of fructose, malabsorption of glucose or galactose, sucrase/isomaltase deficit
- •14.Any other condition which according to the investigatorââ?¬•s judgement is not compatible with the principles of the study, e.g. inability to give informed consent, inability to complete the diary.
- •15.Patients whom positive Covid-19 test
研究者
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