ACTRN12609000976280招募中2 期
Evaluation of natural human interferon alpha lozenges in the prevention of winter colds and flu amongst healthy volunteers in Perth, Western Australia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •healthy volunteer exposed to colds and flu through occupational or community exposure
排除标准
- •- is currently exhibiting an acute upper respiratory tract infection
- •- has a history of a chronic respiratory disease such as asthma requiring any form of regular therapy, bronchitis, Chronic Obstructive Pulmonary Disease (COPD), etc
- •- has any other condition likely to increase the risk of severe or complicated influenza, as outlined in the Australian Immunisation Guidelines (8th ed) such as chronic cardiac diseases, chronic renal disease, endocrine diseases (including diabetes) and immunosuppressive therapy.
- •- any neurological, psychiatric or psychological condition requiring regular medical attention.
- •- any other serious, uncontrolled disease.
- •- any condition requiring regular treatment with antihistamines, or analgesics/antipyretics (including aspirin, paracetemol and non-steroidal anti-inflammatory drugs.
- •- has participated in another clinical trial during the last 12 weeks
- •- has hypersensitivity to Interferon alpha (IFNa)
- •- has known contraindication to any component of IFNa or the placebo
- •- has a concurrent diseases which exclude the administration of therapy as outlined by the study protocol
- •- has active infections requiring systemically administered antibiotics or antiviral medications
- •- has any abnormalities o the screening tests for hepatic, renal and haemtological function.
- •- is non-ambulatory
- •- is a women who is lactating, pregnant or of childbearing potential and not using a reliable contraceptive method
- •- has known Human Immunodeficiency Virus (HIV) or active chronic hepatitis B or C infection
- •- is a subject who, in the opinion of the investigator, is not likely to complete the study for what ever reason.
- •- is a subject who, in the opinion of the investigator, abuses alcohol or drugs
- •- has had previous exposure to parenteral interferon therapy within 12 months
研究者
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