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The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. The primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol nasal spray | Active Comparator | 2 sprays per nostril 3 times a day for a period of two months |
|
| Placebo | Placebo Comparator | 2 sprays per nostril 3 times a day for a period of two months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol nasal spray | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal symptom severity | Nasal symptoms (itching, sneezing, rhinorrhea, and obstruction) will be scored by a four-point scale (0=no symptom; 1=mild; 2= moderate; 3= severe) and record by parents on a daily diary card. | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Cough | The cough presence and severity will be assessed during the day and the night by four-point scale and recorded by parents on a daily diary card. | two years |
| Wheezing | Wheezing will be assessed using the same four-point scale and record by parents on a daily diary card. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second University of Naples | Naples | Italy | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24983742 | Derived | Miraglia Del Giudice M, Maiello N, Capristo C, Alterio E, Capasso M, Perrone L, Ciprandi G. Resveratrol plus carboxymethyl-beta-glucan reduces nasal symptoms in children with pollen-induced allergic rhinitis. Curr Med Res Opin. 2014 Oct;30(10):1931-5. doi: 10.1185/03007995.2014.938731. Epub 2014 Jul 7. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D015508 | Nasal Obstruction |
| D012912 | Sneezing |
| D011537 | Pruritus |
| D000086722 | Rhinorrhea |
| D012141 | Respiratory Tract Infections |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| two year |
| Albuterol use | The albuterol use on demand will be record by parents on a daily diary card. | two years |
| Fever | The days with fever will be record by parents on a daily diary card. | two years |
| School absences | School absences will be record by a diary card. | two years |
| Antihistamines use | Evaluation of Cetirizine syrup on-demand use will be record by parents on a diary card | two years |
| Emergency visits | Emergency room visits for respiratory problems will be record by parents on a diary card. | two years |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D007239 | Infections |