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Single-center, randomized, placebo-controlled study to:
Secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue scales for rhinitis, quality of life and quality of sleep, and the effect on objective parameters, i.e. nasal nitric oxide (nNO) levels, nasal cytology and acoustic rhinometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol plus Carboxymethyl-β-Glucan | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol plus Carboxymethyl-β-Glucan | Drug | Patients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Interleukin-17 (IL-17) | IL-17 level at baseline | Baseline |
| Nasal Interleukin-23 (IL-23) | IL-23 level at baseline | Baseline |
| Nasal Interferon-γ (INF-γ) | INF-γ level at baseline | Baseline |
| Nasal PH | Nasal PH at baseline | Baseline |
| Nasal Interleukin-5 (IL-5) | Mean change in IL-5 level from baseline to the end of treatment. | Baseline and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total 5 Symptom Score (T5SS) | Mean change in T5SS score from baseline to the end of treatment. | Baseline and 28 days |
| Visual Analogue Scale for Rhinitis (VAS) | Mean change in VAS score from baseline to the end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo | Palermo | 90146 | Italy |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks |
|
| Baseline and 28 days |
| Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) | Mean change in PRQLQ score from baseline to the end of treatment. | Baseline and 28 days |
| Pittsburgh Sleep Quality Index (PSQI) | Mean change in PSQI score from baseline to the end of treatment. | Baseline and 28 days |
| Nasal Exhaled Nitric Oxide (nNO) | Mean change of nNO from baseline to the end of treatment. | Baseline and 28 days |
| Nasal Cytology | Mean change in nasal cytology counts from baseline to the end of treatment. | Baseline and 28 days |
| Acoustic Rhinometry: Minimal Cross-sectional Area (MCA) | Mean change of MCA from baseline to the end of treatment. | Baseline and 28 days |
| Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5) | Mean change of V.0-5 from baseline to the end of treatment. | Baseline and 28 days |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |