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

Cough, Acute Clinical Trial

— BROMETOSS  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01356693
• Other study ID #: Brom1
• Status: Unknown status
• Phase: Phase 4
• First received: May 12, 2011
• Last updated: June 27, 2011
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2011
• Source: Universidade Federal de Pernambuco
• Contact: Emanuel SC Sarinho, MD, PhD
• Phone: 55-81-88814801
• Email: emanuel.sarinho[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 102
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Cough, Acute

Intervention

Drug:
• Bromelin
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 with mimicking characteristics of experimental drug

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas/UFPE	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2012;8:CD001831. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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