A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction
NCT ID: NCT01248325
Last Updated: 2010-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2011-01-31
2011-07-31
Brief Summary
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The subjects will use the study medication or comparative, according to their randomization, for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after initiation of treatment.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Luffa Operculate Nasal Solution 5mg/mL
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Luffa Operculate Nasal Solution 5mg/mL
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Saline Solution (NaCl 0,9%)
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Saline Solution (NaCl 0,9%)
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Interventions
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Luffa Operculate Nasal Solution 5mg/mL
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Saline Solution (NaCl 0,9%)
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
Eligibility Criteria
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Inclusion Criteria
* Presence of nasal congestion due to colds, rhinitis, influenza, sinusitis and acute or chronic sinusitis
* Sign the Informed Consent Form
* Comply the study requirements and attend to study visits
* Female subjects must have a NEGATIVE urine pregnancy test during the screening.
Exclusion Criteria
* Subject pregnant, lactating or of childbearing potential and not using adequate and effective contraceptive
* Vasoconstrictor nasal topic or oral
* Use of a decongestant nasal whatever the route of administration
* Use of intranasal corticosteroids
* Use of antiallergic
* Use of medication containing atropine
* Subjects that are participating in another study or who participated in another study, less than 12 months
* Any subjects deemed unsuitable for study by the Principal Investigator
* Abuse of alcohol or illicit drugs
18 Years
90 Years
ALL
No
Sponsors
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Zurita Laboratorio Farmaceutico Ltda.
INDUSTRY
Responsible Party
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Zurita Laboratório Farmacêutico Ltda
Principal Investigators
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Luis Gregório, doctor's
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
Locations
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Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Other Identifiers
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ZUR-LO-2009
Identifier Type: -
Identifier Source: org_study_id