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A Randomized, Double-blind, Prospective, Multicentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies
The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment. The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.
STUDY DESIGN * randomized,double blind, prospective, multicentric, parallel group, intent to treat trial * Experiment duration: 3 days * 2 visits (days 0 and 2) * Evaluation of symptoms reduction * Adverse events evaluation
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
January 1, 2013
Primary Completion Date
August 31, 2013
Completion Date
April 30, 2014
Last Updated
January 25, 2019
132
ACTUAL participants
naphazoline hydrocloride
DRUG
Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
DRUG
Lead Sponsor
EMS
NCT07484061
NCT07484009
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06499701