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

Zurita Laboratorios

Status and phase: Unknown; Phase 3

Conditions: Rhinitis; Sinusitis

Treatments: Drug: Saline Solution (NaCl 0,9%); Drug: Luffa Operculate Nasal Solution 5mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01248325

ZUR-LO-2009

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Luffa Operculate Nasal Solution 5mg/mL

Experimental group

Description:

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.

Treatment:

Drug: Luffa Operculate Nasal Solution 5mg/mL

Saline Solution (NaCl 0,9%)

Active Comparator group

Description:

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.

Treatment:

Drug: Saline Solution (NaCl 0,9%)