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

Cough, Acute research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cough, Acute

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Drug:PlaceboPlacebo with mimicking characteristics of experimental drug

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Unknown status

Start Date: June 2011

Completed Date: March 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change in score in a cough evaluation questionnaire

Secondary Outcome: Change in Occurrence of gastric symptoms

Study sponsors, principal investigator, and references

Principal Investigator: Decio M Peixoto, MD, PhD

Lead Sponsor: Universidade Federal de Pernambuco

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01356693

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.

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