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

Randomized,Double-blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of the Phytotherapic Compound "Bromelin" on Acute Irritative Cough

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.

Study Overview

• Status: Unknown
• Conditions: Cough, Acute
• Intervention / Treatment: Drug: Bromelin; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emanuel SC Sarinho, MD, PhD; Phone Number: 55-81-88814801; Email: emanuel.sarinho@gmail.com

Study Locations

• Brazil
  • PE
    • Recife, PE, Brazil, 50670-901
      • Recruiting
      • Hospital das Clínicas/UFPE
      • Contact: Emanuel S Sarinho, MD, PhD; Phone Number: 55-81-88814801; Email: emanuel.sarinho@gmail.com
      • Contact: Decio M Peixoto, MD, PhD; Phone Number: 55-81-86636709; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before and 10 and 30 minutes after the dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Occurrence of gastric symptoms	Question "YES" as answer to questions about gastric symptoms as nausea and/or vomiting after medication	10 and 30 minutes

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Study Director: Decio M Peixoto, MD, PhD, UFPE; Principal Investigator: Emanuel SC Sarinho, MD, PhD, UFPE

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Adolescent; Child; Cough; Common cold
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: Brom1