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Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough (BROMETOSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356693
Recruitment Status : Unknown
Verified March 2011 by Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : May 19, 2011
Last Update Posted : June 28, 2011
Information provided by:
Universidade Federal de Pernambuco

Brief Summary:

Cough is the most bothersome symptom for patients with the common cold.

The objective of the study is to compare the phytotherapic "Bromelin", a compound preparation of honey from the bee apis mellifera with the extract of the pineapple (Ananas comosus) with placebo in reducing cough episodes in patients with the common cold.

Condition or disease Intervention/treatment Phase
Cough, Acute Drug: Bromelin Drug: Placebo Phase 4

Detailed Description:

Common cold is very frequent and cough is one of the most troublesome symptoms. Over-the-counter medications are used by patients without prescription, many times with important side effects.

Bromelin, a compound made with honey and pineapple extract could offer cough symptomatic relief as a soothing agent.

This study aims to compare this compound with placebo in reducing cough in patients with common cold in an clinical trial designed in conformity to CONSORT guidelines.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized,Double-blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of the Phytotherapic Compound "Bromelin" on Acute Irritative Cough
Study Start Date : June 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Active drug
Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.
Drug: Bromelin
Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose.
Other Names:
  • Bromelein
  • Ananas comosus extract

Placebo Comparator: Placebo
Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.
Drug: Placebo
Placebo with mimicking characteristics of experimental drug

Primary Outcome Measures :
  1. Change in score in a cough evaluation questionnaire [ Time Frame: before and 10 and 30 minutes after the dosing ]
    A cough score based on number of coughing episodes and subjective 5 item cough score : no cough, mild, moderate, severe, very severe.

Secondary Outcome Measures :
  1. Change in Occurrence of gastric symptoms [ Time Frame: 10 and 30 minutes ]
    Question "YES" as answer to questions about gastric symptoms as nausea and/or vomiting after medication

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • cough for less than 24 hours
  • common cold symptoms : nasal obstruction, headache, myalgias, runny nose.

Exclusion Criteria:

  • declared chronic pulmonary diseases declared Nervous diseases declared Diabetes declared cardiac diseases known primary or secondary immunodeficiencies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356693

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Contact: Emanuel SC Sarinho, MD, PhD 55-81-88814801

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Hospital das Clínicas/UFPE Recruiting
Recife, PE, Brazil, 50670-901
Contact: Emanuel S Sarinho, MD, PhD    55-81-88814801   
Contact: Decio M Peixoto, MD, PhD    55-81-86636709   
Sub-Investigator: Jose A Rizzo, MD, PhD         
Sub-Investigator: Dinaldo C Oliveira, MD, PhD         
Sub-Investigator: Almerinda R silva, MD, MsC         
Sponsors and Collaborators
Universidade Federal de Pernambuco
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Study Director: Decio M Peixoto, MD, PhD UFPE
Principal Investigator: Emanuel SC Sarinho, MD, PhD UFPE

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Emanuel Sávio Cavalcanti Sarinho, Universidade Federal de Pernambuco Identifier: NCT01356693     History of Changes
Other Study ID Numbers: Brom1
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: March 2011
Keywords provided by Universidade Federal de Pernambuco:
Common cold
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sodium Benzoate
Antifungal Agents
Anti-Infective Agents