Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough (BROMETOSS)
Recruitment status was: Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Randomized,Double-blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of the Phytotherapic Compound "Bromelin" on Acute Irritative Cough|
- Change in score in a cough evaluation questionnaire [ Time Frame: before and 10 and 30 minutes after the dosing ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Question "YES" as answer to questions about gastric symptoms as nausea and/or vomiting after medication
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356693
|Hospital das Clínicas/UFPE|
|Recife, PE, Brazil, 50670-901|
|Study Director:||Decio M Peixoto, MD, PhD||UFPE|
|Principal Investigator:||Emanuel SC Sarinho, MD, PhD||UFPE|