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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01356693

Acronym

BROMETOSS

Enrollment

102

Registered

2011-05-19

Start date

2011-06-30

Completion date

2012-03-31

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough, Acute

Keywords

Cough, Common cold, Child, Adolescent

Brief summary

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

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.

Interventions

DRUGBromelin

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

DRUGPlacebo

Placebo with mimicking characteristics of experimental drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

2 Years to 15 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in score in a cough evaluation questionnaire	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.

Secondary

Measure	Time frame	Description
Change in Occurrence of gastric symptoms	10 and 30 minutes	Question YES as answer to questions about gastric symptoms as nausea and/or vomiting after medication

Countries

Brazil

Contacts

Primary ContactEmanuel SC Sarinho, MD, PhD

emanuel.sarinho@gmail.com55-81-88814801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026