Clinical trial NCT01356693: Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough
Official title: Randomized,Double-blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of the Phytotherapic Compound "Bromelin" on Acute Irritative Cough
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cough, Acute
Keywords: Cough
Common cold
Child
Adolescent
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 102
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in score in a cough evaluation questionnaire
timeFrame: before and 10 and 30 minutes after the dosing
Secondary outcomes:
measure: Change in Occurrence of gastric symptoms
timeFrame: 10 and 30 minutes
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital das Clínicas/UFPE
state: PE
Study officials:
affiliation: UFPE
name: Decio M Peixoto, MD, PhD
role: STUDY_DIRECTOR
affiliation: UFPE
name: Emanuel SC Sarinho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith SM, Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001831. doi: 10.1002/14651858.CD001831.pub3.
citation: Widdicombe J, Morice A. Over the counter cough medicines for acute cough. Good quality research is needed. BMJ. 2002 May 11;324(7346):1158. No abstract available.
citation: Gardner JF. Regulation of the threonine operon: tandem threonine and isoleucine codons in the control region and translational control of transcription termination. Proc Natl Acad Sci U S A. 1979 Apr;76(4):1706-10. doi: 10.1073/pnas.76.4.1706.
citation: Peixoto DM, Rizzo JA, Schor D, Silva AR, Oliveira DC, Sole D, Sarinho E. Use of honey associated with Ananas comosus (Bromelin) in the treatment of acute irritative cough. Rev Paul Pediatr. 2016 Dec;34(4):412-417. doi: 10.1016/j.rpped.2016.03.006. Epub 2016 Apr 16.