CTRI/2011/07/001914已完成3 期
A Randomized, Prospective, Open label, Parallel group, Comparative,Multi-Center Study to Determine the Safety and Efficacy of Truteksdevice Multi Acting Nasal Particle Blocker (MAPB) as a PreventiveTreatment for Cold and Flu.
Trutek Corp3 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2011年7月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- The percentage of subjects that are cold and/or flu free in the treatment arm
研究概览
简要总结
A Randomized, Prospective, Open label, Parallel group, Comparative, Multi-Center Study to Determine the Safety and Efficacy of Truteks device Multi Acting Nasal Particle Blocker (MAPB) as a Preventive Treatment for Cold and Flu.
Study Objectives:
The primary objective of the study is:
1.To evaluate the efficacy of MAPB Nasal Application Gel in the prevention of the common cold and/or flu.
The secondary objective of the study is:
1.To evaluate the safety of MAPB Nasal Application Gel in the prevention of the common cold and/or flu.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female subjects, 18 to70 years (inclusive) of age.
- •Willing to sign the written informed consent form.
- •Willingness to comply with the test procedure.
排除标准
- •Exclusion Criteria: Subjects who are more at risk for cold and/or flu or cold and/or flu complications than the general population such as serious respiratory problems, immune system disorders, and serious heart problems or individuals with other serious health problems may be excluded from the study if, at the discretion of the Principal Investigator, their participation would constitute a threat to their health.
- •Subjects who report any two or more of the cold and/or flu symptoms in the past seven days with at least one significantly worsening in the past 1 to 4 days may be construed to have acquired cold and/or flu and excluded from the study.
- •Subjects who have planned travel outside study area for a substantial portion of the study period.
- •Subjects who have gotten the flu shot within the last twelve months will not be allowed to participate.
- •Pregnant or nursing subjects.
- •(There are, however, no risks for pregnant women and fetus by use, as directed, of the test article.)
- •Subjects who have had a life-threatening health emergency within the last six months will not be allowed to participate.
- •Subjects who have received any investigational product within 30 days of enrollment.
- •Subjects who have history of allergic rhinitis expected to occur during the study period.
- •Subjects who have used any antiviral influenza medications within 2 weeks of screening or during the study period.
- •Subjects who have documented infection within two weeks prior to screening.
- •Subjects who have any chronic medical condition treated within 3 months prior to screening.
- •Subjects who have any systemic immunologic or immunosuppressive diseases.
- •Subjects who are scheduled for surgery during the study period.
结局指标
主要结局
The percentage of subjects that are cold and/or flu free in the treatment arm
时间窗: At the end of study(Day 57)
次要结局
- Incidence of treatment related adverse events.(The percentage of subjects that are cold and/or flu free in the treatment arm)
研究者
研究点 (3)
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