Effect Of Piperine In Patients With Oropharyngeal Dysphagia

NCT ID: NCT01383694

Last Updated: 2015-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Deglutition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Piperine Dose 1

Piperine 1 mM

Group Type EXPERIMENTAL

Piperine

Intervention Type DRUG

Piperine Dose 2

Piperine 150 microM

Group Type EXPERIMENTAL

Piperine

Intervention Type DRUG

Interventions

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Piperine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de MatarĂ³

OTHER

Sponsor Role lead

Responsible Party

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Pere Clave

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de MatarĂ³

MatarĂ³, Barcelona, Spain

Site Status

Countries

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Spain

Related Links

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Other Identifiers

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FIS 22/09

Identifier Type: -

Identifier Source: org_study_id

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