Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough (BROMETOSS)
|ClinicalTrials.gov 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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
Experimental: Active drug
Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.
Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose.
Placebo Comparator: Placebo
Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.
Placebo with mimicking characteristics of experimental drug
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356693
|Contact: Emanuel SC Sarinho, MD, PhDfirstname.lastname@example.org|
|Hospital das Clínicas/UFPE||Recruiting|
|Recife, PE, Brazil, 50670-901|
|Contact: Emanuel S Sarinho, MD, PhD 55-81-88814801 email@example.com|
|Contact: Decio M Peixoto, MD, PhD 55-81-86636709 firstname.lastname@example.org|
|Sub-Investigator: Jose A Rizzo, MD, PhD|
|Sub-Investigator: Dinaldo C Oliveira, MD, PhD|
|Sub-Investigator: Almerinda R silva, MD, MsC|
|Study Director:||Decio M Peixoto, MD, PhD||UFPE|
|Principal Investigator:||Emanuel SC Sarinho, MD, PhD||UFPE|