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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01248325

Enrollment

Registered

2010-11-25

Start date

2011-01-31

Completion date

2011-07-31

Last updated

2010-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Sinusitis

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.

Interventions

DRUGLuffa 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.

DRUGSaline 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Brazil

Contacts

Primary ContactAndréa Martinez, doctor's

andrea.martinez@avantipc.com.br(11 55) 5082-3634

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026