Capsaicin for Post-stroke Dysphagia (NCT04470752) | Clinical Trial Compass
UnknownPhase 2
Capsaicin for Post-stroke Dysphagia
Switzerland82 participantsStarted 2021-08-24
Plain-language summary
Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Diagnosis other than ischemic stroke
* Late patient admission \>48 hours after stroke onset
* Impairment of functional oral intake scale ≥ 5
* FEES \>72h after admission
* PAS \<2
* 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