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

Universidade Federal de Pernambuco

Status and phase: Unknown; Phase 4

Conditions: Cough, Acute

Treatments: Drug: Placebo; Drug: Bromelin

Study type: Interventional

Funder types: Other

Identifiers

NCT01356693

Brom1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

Active drug

Experimental group

Description:

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

Treatment:

Drug: Bromelin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo