Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT04162795
Eligibility Criteria:
Inclusion Criteria:
* Female or male adults aged 18 to 65 years of age inclusive
* Were in good general health
* Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
* Agreed to not use antihistamine products 24 hours before and after the treatment
* Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing
Exclusion Criteria:
* Individuals who had used oral/systemic medications 24 hours before the first administration of test product
* Individuals who used medications which might influence taste perception
* Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
* Women who were pregnant or thinking of becoming pregnant or were nursing
* Participants with congestion at the time of study visit
* Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day
* Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)
* History of alcohol or drug abuse
* History of hypersensitivity or allergic reactions to any ingredients in the test product
* Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties
* Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04162795
Study Brief:
Protocol Section:
NCT04162795