A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction

Phase 3

• Conditions: Rhinitis; Sinusitis
• Interventions: Drug: Luffa Operculate Nasal Solution 5mg/mL; Drug: Saline Solution (NaCl 0,9%)

• Registration Number: NCT01248325
• Lead Sponsor: Zurita Laboratorio Farmaceutico Ltda.

Brief Summary

Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1 ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL, Group B: saline).

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

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-23
• Last Update Submitted: 2010-11-23
• Study First Posted: 2010-11-25
• Last Update Posted: 2010-11-25
• Study Start: 2011-01
• Primary Completion: 2011-07
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subjects of both sexes aged over 18 years.
• 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

• Known allergy to any study product component
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Luffa Operculate Nasal Solution 5mg/mL	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%)	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.

Primary Outcome Measures

Name	Time	Method
Improvement of nasal congestion	3 days	If the patient present a improvement of nasal congestion 3 days after the treatment start, the treatment will be discontinued and the patient will perfomr the Visit 2.

Trial Locations

Locations (1)

Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP; 🇧🇷 São Paulo, Brazil