Capsaicin for Post-stroke Dysphagia

BASEC 2020-01362

Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.

2021-08-24

2024-12-01

2024-12-01

Recruiting

Early phase I

82

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

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2023-06-22