Effect Of Piperine In Patients With Oropharyngeal Dysphagia

Phase 1

Completed

• Conditions: Deglutition Disorders
• Interventions: Drug: Piperine

• Registration Number: NCT01383694
• Lead Sponsor: Hospital de Mataró

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-27
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age>18
• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piperine Dose 1	Piperine	Piperine 1 mM
Piperine Dose 2	Piperine	Piperine 150 microM

Primary Outcome Measures

Name	Time	Method
Safety of swallow	15 minutes	Prevalence of penetrations at the laryngeal vestibule

Secondary Outcome Measures

Name	Time	Method
Efficacy of swallow	15 minutes	Prevalence of oral and pharyngeal residue

Trial Locations

Locations (1)

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain