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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cough, Acute

Intervention / Treatment
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* Drug: Bromelin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active drug<br>Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml. | Drug: Bromelin<br>* Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose.<br>* Other names: Ananas comosus extract;|
| Placebo Comparator: Placebo<br>Placebo comparator with the same characteristics of experimental drug, 5ml, single dose. | Drug: Placebo<br>* Placebo with mimicking characteristics of experimental drug<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cough, Common cold, Child, Adolescent