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?
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
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.
Start Date: June 2011
Completed Date: March 2012
Phase: Phase 4
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
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.