Capsaicin for Post-stroke Dysphagia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Penetration Aspiration Scale (PAS) score
研究概览
简要总结
Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.
详细描述
After inclusion and the assessment of the swallowing function (PRESS, PAS, FOIS, FEES) patients will be randomised 1:1 to receive 1mcg Capsaicin or Placebo. Oral treatment will be applied 3 times daily either during meals or during regular swallowing tests/trainings accompanied by a Speech Language Pathologist. After re-assessment of the dysphagia after 7 days, patients with persistent dysphagia and applicable for further treatment will be treated for another 23 days with a final clinical swallowing evaluation after a total of 30 days. A Patient Medication Diary will used during the Duration of the Trial to capture compliance.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both study drug and Placebo have identical packaging (brown glass bottle) and labeling (Capsaicin or Placebo). Both use the same liquid suspension, same colour, and consistency..
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
- •Acute ischemic Stroke
- •Impairment of oral intake with FOIS ≤ 4
- •Magnetic Resonance Imaging of the brain or CT scan with the finding of a subacute ischemic stroke
- •Informed Consent within 48 hours after admission, following initial swallowing assessment
排除标准
- •Diagnosis other than ischemic stroke
- •Late patient admission >48 hours after stroke onset
- •Impairment of functional oral intake scale ≥ 5
- •FEES >72h after admission
- •Pre-existing dysphagia
- •Dysphagia due to other cause
- •No evidence of stroke on imaging
- •Recurrent stroke = at least one stroke in the course of the study apart from the index stroke
- •Age <18 years
- •Current drug abuse
- •Amphetamine or amphetamine-like Medication
- •Regular oral treatment with chilli pepper extract
- •Allergies or known adverse reactions to the consumption of chilli pepper or capsaicin
- •Personality disorder
- •Severe dementia or delirium
- •Other reasons according to physician/investigator because of which the patient cannot participate in the study (not suitable for treatment or examinations)
- •withdrawal of consent by participant at any time of the study
研究组 & 干预措施
Placebo
InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.
干预措施: InOrpha Solution (Drug)
Capsaicin
InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days.
干预措施: Capsaicin 1% oral solution (Drug)
结局指标
主要结局
Penetration Aspiration Scale (PAS) score
时间窗: 7 days after randomisation
the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission.
次要结局
- Functional Oral Intake Scale (FOIS) score(at day 7 and 30 post admission)
- number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement(from randomisation until day 30)
- Latency of the Swallowing reflex(from randomisation until day 30)
- Swallowing quality of life questionnaire (Swal-QoL) score(from randomisation until day 30)
- Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke(after 7 and 30 days post admission)
- Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke(after 7 and 30 days post admission)
- days of nasogastric tube feeding(from randomisation until day 30)
- number of patients with aspiration pneumonia(from randomisation until day 30)
- modified Ranking Scale (mRS) score(from randomisation until day 30)
研究者
Georg Kägi, MD
Senior Physician and Head of the Stroke Center
Cantonal Hospital of St. Gallen