BROMETOSS: Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active drug Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml. |
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.
Other Names:
|
| Placebo Comparator: Placebo Placebo comparator with the same characteristics of experimental drug, 5ml, single dose. |
Drug: Placebo
Placebo with mimicking characteristics of experimental drug
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital das Clínicas/UFPE | Recife | PE | Brazil | 50670-901 |
Sponsors and Collaborators
- Universidade Federal de Pernambuco
Investigators
- Study Director: Decio M Peixoto, MD, PhD, UFPE
- Principal Investigator: Emanuel SC Sarinho, MD, PhD, UFPE
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Widdicombe J, Morice A. Over the counter cough medicines for acute cough. Good quality research is needed. BMJ. 2002 May 11;324(7346):1158.
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