NCT01356693

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 28, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

May 12, 2011

Last Update Submit

June 27, 2011

Conditions

Cough, Acute

Keywords

CoughCommon coldChildAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Occurrence of gastric symptoms

    10 and 30 minutes

Study Arms (2)

Active drug

EXPERIMENTAL

Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.

Drug: Bromelin

Placebo

PLACEBO COMPARATOR

Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.

Drug: Placebo

Interventions

BromelinDRUG

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

Also known as: Bromelein, Ananas comosus extract
Active drug
PlaceboDRUG

Placebo with mimicking characteristics of experimental drug

Placebo

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • cough for less than 24 hours
  • common cold symptoms : nasal obstruction, headache, myalgias, runny nose.

You may not qualify if:

  • declared chronic pulmonary diseases declared Nervous diseases declared Diabetes declared cardiac diseases known primary or secondary immunodeficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das ClĂ­nicas/UFPE

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18253996BACKGROUND

  • 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.

    PMID: 12008729BACKGROUND

  • 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.

    PMID: 287010BACKGROUND

  • 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.

    PMID: 27181342DERIVED

MeSH Terms

Conditions

CoughCommon Cold

Interventions

Bromelains

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus Diseases

Intervention Hierarchy (Ancestors)

Cysteine EndopeptidasesCysteine ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidases

Study Officials

  • Decio M Peixoto, MD, PhD

    UFPE

    STUDY DIRECTOR

  • Emanuel SC Sarinho, MD, PhD

    UFPE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuel SC Sarinho, MD, PhD

CONTACT

55-81-88814801emanuel.sarinho@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 19, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

June 28, 2011

Record last verified: 2011-03

Locations

BR(1)