NCT01383694已完成1 期
Effect of Natural Agonists of TRPV1 in the Treatment of Functional Oropharyngeal Dysphagia in Neurological Diseases and the Elderly: Piperine
Hospital de Mataró1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety of swallow
研究概览
简要总结
Piperine acts on the oropharyngeal TRPV1, increasing sensory input and the release of substance P. These actions may accelerate the oropharyngeal swallow response, improving the swallowing of dysphagic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of swallowing difficulties associated with aging and/or neurological diseases (neurodegenerative or non-progressive neurological diseases)
- •Study explained and written subject information given
- •Informed consent signed
排除标准
- •Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media
- •Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study
- •Patients with a background of alcohol dependence or other drug dependence
- •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of the study
研究组 & 干预措施
Piperine Dose 1
Experimental
Piperine 1 mM
干预措施: Piperine (Drug)
Piperine Dose 2
Experimental
Piperine 150 microM
干预措施: Piperine (Drug)
结局指标
主要结局
Safety of swallow
时间窗: 15 minutes
Prevalence of penetrations at the laryngeal vestibule
次要结局
- Efficacy of swallow(15 minutes)
研究者
Pere Clave
MD, PhD
Hospital de Mataró
研究点 (1)
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