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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Universidade Federal de Pernambuco.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01356693
First received: May 12, 2011
Last updated: June 27, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Cough, Acute
Drug: Bromelin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • Change in score in a cough evaluation questionnaire [ Time Frame: before and 10 and 30 minutes after the dosing ] [ Designated as safety issue: Yes ]
    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:
  • Change in Occurrence of gastric symptoms [ Time Frame: 10 and 30 minutes ] [ Designated as safety issue: Yes ]
    Question "YES" as answer to questions about gastric symptoms as nausea and/or vomiting after medication


Estimated Enrollment: 102
Study Start Date: June 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356693

Contacts
Contact: Emanuel SC Sarinho, MD, PhD 55-81-88814801 emanuel.sarinho@gmail.com

Locations
Brazil
Hospital das Clínicas/UFPE Recruiting
Recife, PE, Brazil, 50670-901
Contact: Emanuel S Sarinho, MD, PhD    55-81-88814801    emanuel.sarinho@gmail.com   
Contact: Decio M Peixoto, MD, PhD    55-81-86636709    daph@elogica.com.br   
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
Investigators
Study Director: Decio M Peixoto, MD, PhD UFPE
Principal Investigator: Emanuel SC Sarinho, MD, PhD UFPE
  More Information

Additional Information:
Publications:
Responsible Party: Emanuel Sávio Cavalcanti Sarinho, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01356693     History of Changes
Other Study ID Numbers: Brom1
Study First Received: May 12, 2011
Last Updated: June 27, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Universidade Federal de Pernambuco:
Cough
Common cold
Child
Adolescent

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014