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 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT03794804
Eligibility Criteria:
Inclusion Criteria:
1. Men and women
2. Age 18 to 70 years old
3. Increased risk for common cold (at least 3 self-reported occurences of common cold within the last 12 months prior to V1) but generally in good health
4. Readiness to comply with trial procedures, including in particular:
* Use of IP as recommended
* Filling in diary
* Keeping habitual life-style, including diet and physical activity level
* No use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, anti-tussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) during the study (except for the defined "rescue" treatment)
5. Women of child-bearing potential:
* Have to agree to use appropriate contraception methods
* Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature,
Exclusion Criteria:
1. Known allergy or hypersensitivity to the components of the investigational product
2. History and/or presence of clinically significant condition/ disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
* Nasal disorder (e.g. polyposis, relevant septal deviation, ulcer etc.) and/or reconstructive surgery
* Asthma, chronic obstructive lung disease or any other acute/chronic airways disease/disorder (e.g. chronic cough of any origin)
* Acute psychiatric disorders
* Any other acute/chronic serious organ or systemic diseases
3. Influenza vaccination within the last 3 months prior to V1 and during the study
4. Regular use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1
5. Pregnancy or nursing
6. History of (in the past 12 months prior to V1) or current abuse of drugs, alcohol or medication
7. Participation in the present study of a person living in the same household as the subject
8. Inability to comply with study requirements according to investigator's judgement
9. Participation in another clinical study in the 30 days prior to V1 and during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03794804
Study Brief:
Protocol Section:
NCT03794804