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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-03-31

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.

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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.

Conditions

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Cough, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Active drug

Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.

Group Type EXPERIMENTAL

Bromelin

Intervention Type DRUG

Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose.

Placebo

Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with mimicking characteristics of experimental drug

Interventions

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Bromelin

Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose.

Intervention Type DRUG

Placebo

Placebo with mimicking characteristics of experimental drug

Intervention Type DRUG

Other Intervention Names

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Bromelein Ananas comosus extract

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No