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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trial Unicenter, Phase III, Randomized, Double-blind, Comparative to Evaluate the Efficacy, Tolerability and Superiority of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline Solution in the Relief of Nasal Obstruction.

Conditions
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Rhinitis, Sinusitis

Intervention / Treatment
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* Drug: Luffa Operculate Nasal Solution 5mg/mL
* Drug: Saline Solution (NaCl 0,9%)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luffa Operculate Nasal Solution 5mg/mL<br>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. | Drug: Luffa Operculate Nasal Solution 5mg/mL<br>* 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.<br>|
| Active Comparator: Saline Solution (NaCl 0,9%)<br>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. | Drug: Saline Solution (NaCl 0,9%)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of nasal congestion | 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. | 3 days |