J30.1
Conditions
Interventions
Group 1: Oral administration of dietary supplement tablet (Narivent oral soluble tablet) consisting of quail egg powder 84 mg and zinc 1.5 mg (for 2 tablets), twice a day, plus 100 mcg Mometasone nasa
Sponsors
University of Catania
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients were eligible to participate if the following inclusion criteria were met: - age =18 years old; - recent diagnosis/clinically relevant history of mild to severe SAR to the most common inhalant allergens prevalent in the geographic area in which the study was carried out; - who did not receive any treatment for SAR.
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if they had any medical condition, such as pregnancy, a respiratory tract infection that could influence the study; uncontrolled asthma; taking an antihistamine, leukotriene receptor antagonist, and decongestant within the week before the study participation; consumption of corticosteroids within the month before the study participation; or known sensitivities to any of the ingredients of the study product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of a quail egg homogenate-based dietary supplement as adjunctive therapy in patients with seasonal allergic rhinitis assessed by the mean change (pre-treatment / post-treatment) in Total Symptoms Score (TSS) which included four parameters related to symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing). The intensity was calculated by total and individual nasal symptoms score using a numerical score scale (0 – no symptoms, 3 – severe) Timepoint: Baseline to week 4 inclusive | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Rhinitis Control Assessment Test (RCAT). A self-administered instrument for evaluating symptom control in patients with rhinitis. 5-point Likert scale ("never" to "extremely often"), scores range from 6 to 30, with scores < 21 indicating bad rhinitis symptom control. Timepoint: Baseline to week 4 inclusive. - Total Nasal airflow resistance (right+left) (Pa/cm3/s), using an active anterior rhinomanometry. It reflects the resistance of both sides of the nasal cavity. Normal values range is 0.10-0.40 Pa/cm3/s. Timepoint: Baseline to week 4 inclusive. - Total plasma IgE (IU/mL). Timepoint: Baseline to week 4 inclusive. - Rescue medication use (cetirizine 5 mg, once daily). Timepoint: week 4. - Adverse events. Timepoint: week 4. | — |
Countries
Italy
Contacts
Public ContactClaudio Andaloro
University of Catania
Outcome results
None listed