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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug | Experimental | Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml. |
|
| Placebo | Placebo Comparator | Placebo comparator with the same characteristics of experimental drug, 5ml, single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromelin | Drug | Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuel SC Sarinho, MD, PhD | Contact | 55-81-88814801 | emanuel.sarinho@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Decio M Peixoto, MD, PhD | UFPE | Study Director |
| Emanuel SC Sarinho, MD, PhD | UFPE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas/UFPE | Recruiting | Recife | Pernambuco | 50670-901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18253996 | Background | 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. | |
| 12008729 | Background | 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. |
| Label | URL |
|---|---|
| Institutional webpage | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 31, 2017 | |
| Reset | Oct 20, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 31, 2017 | Oct 20, 2017 |
| ID | Term |
|---|---|
| D003371 | Cough |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001963 | Bromelains |
| ID | Term |
|---|---|
| D003546 | Cysteine Endopeptidases |
| D057056 | Cysteine Proteases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| Placebo | Drug | Placebo with mimicking characteristics of experimental drug |
|
| 287010 | Background | 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. |
| 27181342 | Derived | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010450 | Endopeptidases |