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Trial record 2 of 26 for:    methylparaben

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

Tracking Information
First Submitted Date  ICMJE May 12, 2011
First Posted Date  ICMJE May 19, 2011
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01356693 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough
Official Title  ICMJE Randomized,Double-blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of the Phytotherapic Compound "Bromelin" on Acute Irritative Cough
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Cough, Acute
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo with mimicking characteristics of experimental drug
Study Arms  ICMJE
  • Experimental: Active drug
    Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.
    Intervention: Drug: Bromelin
  • Placebo Comparator: Placebo
    Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 18, 2011)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2012
Estimated Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01356693
Other Study ID Numbers  ICMJE Brom1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emanuel Sávio Cavalcanti Sarinho, Universidade Federal de Pernambuco
Study Sponsor  ICMJE Universidade Federal de Pernambuco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Decio M Peixoto, MD, PhD UFPE
Principal Investigator: Emanuel SC Sarinho, MD, PhD UFPE
PRS Account Universidade Federal de Pernambuco
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP