ACTRN12620000701921撤回1 期
Safety and tolerance of manuka honey for use as a nebulizer solution in a group of healthy volunteers
ManukaMed LP0 个研究点目标入组 15 人开始时间: 2020年6月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 15
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1.Be able and willing to give written informed consent,
- •2.Understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator,
- •3.Male and female subjects who are 18 to 80 years of age,
- •4.Subjects are not currently ill, or have a history of respiratory or cardiac disease,
- •5.Have vital signs that are within the normal range at time of screening (blood pressure 90/60 to 120/80 mm Hg; pulse 60-100 beats per min; breathing 12-20 breaths per min; temperature 36.5 to 37.3 °C),
- •6.Have lung performance parameters that are within the predicted range for their age and sex at time of screening (European Respiratory Society (ERS), European Community for Coal and Steel (ECCS)/Knudson) provided by the spirometer software (WinspiroPRO).
排除标准
- •1.Subjects who are hypersensitive, or have an allergic reaction to honey, or bee products.
- •2.Subjects who are on medication that may influence pulmonary measurements.
- •3.Subjects who are asthmatics.
- •4.Subjects who are ill (including common cold) on the day, or for the previous week(s).
- •5.Subject has a history or presence of significant cardiovascular disease, including having a cardiac pacemaker,
- •6.Subject has a significant acute or chronic coexisting illness which in the opinion of the investigator, could affect the outcome of the study, including kidney, liver or renal disease/dysfunction, uncontrolled metabolic disease,
- •7.Subject has a history of hypertension or elevated blood pressure (systolic, >140 mmHg or a diastolic, >90 mmHg), unless on stable anti-hypertensive medication for at least 3 months prior to and for the duration of the study,
- •8.Subject has a history of drug and / or alcohol abuse,
- •9.Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
研究者
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