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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luffa Operculate Nasal Solution 5mg/mL | Experimental | 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%) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luffa Operculate Nasal Solution 5mg/mL | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andréa Martinez, doctor's | Contact | (11 55) 5082-3634 | andrea.martinez@avantipc.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Luis Gregório, doctor's | Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP | São Paulo | São Paulo | 04039-032 | Brazil |
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| Saline Solution (NaCl 0,9%) | Drug | 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. |
|
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010254 | Paranasal Sinus Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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