Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough (BROMETOSS)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|