AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female infants and toddlers aged 3 - 48 months (inclusive) at enrolment (Day 0).
✓. Caretaker(s) answering "yes" to the question "Do you feel that your child has a cold?" at enrolment (Day 0).
✓. Subjects with symptoms started within 48 hours prior to enrolment (Day 0).
✓. Subjects with nasal congestion (blocked / stuffy nose) rated as at least grade 2 (moderately bothersome) on a 0 to 2-point scale, based on morning evaluation (within an hour of subject awakening).
✓. Subjects showing at least grade 2 on a 0 to 2-point scale for at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
✓. Legal caretaker(s) signed written informed consent for their young ones to participate in the study.
✓. Legal caretaker(s) willing to comply with all study procedures.
✓. Ability of the caretaker(s) (in the Investigator's opinion) to comprehend the full nature, procedures, and purpose of the study.
Exclusion criteria
✕. Subjects presenting a body temperature greater than 38°C measured with a non-contact infrared thermometer at enrolment (Day 0).
✕. Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment (Day 0).
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What they're measuring
1
Change of nasal congestion.
Timeframe: Through study completion, an average of 10 days
. Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at enrolment (Day 0).
✕. Subjects with history of allergic rhinitis.
✕. Subjects presenting any congenital or chronic disease that in the opinion of the Investigator would adversely affect the results of the study (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, and so on).
✕. Subjects presenting any kind of immunodeficiency.
✕. Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products.
✕. Subjects with a positive medical history to any significant illness within the 2 weeks prior to the enrolment (Day 0).