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

Primary Purpose

Cough, Acute

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Bromelin
Placebo
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough, Acute focused on measuring Cough, Common cold, Child, Adolescent

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas/UFPERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active drug

Placebo

Arm Description

Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.

Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.

Outcomes

Primary Outcome Measures

Change in score in a cough evaluation questionnaire
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
Question "YES" as answer to questions about gastric symptoms as nausea and/or vomiting after medication

Full Information

First Posted
May 12, 2011
Last Updated
June 27, 2011
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01356693
Brief Title
Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough
Acronym
BROMETOSS
Official Title
Randomized,Double-blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of the Phytotherapic Compound "Bromelin" on Acute Irritative Cough
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Acute
Keywords
Cough, Common cold, Child, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active drug
Arm Type
Experimental
Arm Description
Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.
Intervention Type
Drug
Intervention Name(s)
Bromelin
Other Intervention Name(s)
Bromelein, Ananas comosus extract
Intervention Description
Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo with mimicking characteristics of experimental drug
Primary Outcome Measure Information:
Title
Change in score in a cough evaluation questionnaire
Description
A cough score based on number of coughing episodes and subjective 5 item cough score : no cough, mild, moderate, severe, very severe.
Time Frame
before and 10 and 30 minutes after the dosing
Secondary Outcome Measure Information:
Title
Change in Occurrence of gastric symptoms
Description
Question "YES" as answer to questions about gastric symptoms as nausea and/or vomiting after medication
Time Frame
10 and 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuel SC Sarinho, MD, PhD
Phone
55-81-88814801
Email
emanuel.sarinho@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Decio M Peixoto, MD, PhD
Organizational Affiliation
UFPE
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emanuel SC Sarinho, MD, PhD
Organizational Affiliation
UFPE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas/UFPE
City
Recife
State/Province
PE
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuel S Sarinho, MD, PhD
Phone
55-81-88814801
Email
emanuel.sarinho@gmail.com
First Name & Middle Initial & Last Name & Degree
Decio M Peixoto, MD, PhD
Phone
55-81-86636709
Email
daph@elogica.com.br
First Name & Middle Initial & Last Name & Degree
Jose A Rizzo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dinaldo C Oliveira, MD, PhD
First Name & Middle Initial & Last Name & Degree
Almerinda R silva, MD, MsC

12. IPD Sharing Statement

Citations:
PubMed Identifier
18253996
Citation
Smith SM, Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001831. doi: 10.1002/14651858.CD001831.pub3.
Results Reference
background
PubMed Identifier
12008729
Citation
Widdicombe J, Morice A. Over the counter cough medicines for acute cough. Good quality research is needed. BMJ. 2002 May 11;324(7346):1158. No abstract available.
Results Reference
background
PubMed Identifier
287010
Citation
Gardner JF. Regulation of the threonine operon: tandem threonine and isoleucine codons in the control region and translational control of transcription termination. Proc Natl Acad Sci U S A. 1979 Apr;76(4):1706-10. doi: 10.1073/pnas.76.4.1706.
Results Reference
background
PubMed Identifier
27181342
Citation
Peixoto DM, Rizzo JA, Schor D, Silva AR, Oliveira DC, Sole D, Sarinho E. Use of honey associated with Ananas comosus (Bromelin) in the treatment of acute irritative cough. Rev Paul Pediatr. 2016 Dec;34(4):412-417. doi: 10.1016/j.rpped.2016.03.006. Epub 2016 Apr 16.
Results Reference
derived

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

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