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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT02246166
Eligibility Criteria:
Inclusion Criteria:
* Aged at least 18 years and less than 65 years
* Good general and mental health in the opinion of the investigator
* Participants diagnosed with a common cold or flu and must have the following symptoms of at least "moderate" in intensity (≥ 2) at the screening visit (baseline), with a minimum total symptom score of 6:
(i) At least one of pain symptoms: sore throat, headache, or extremities pain (ii) Mandatory: Nasal congestion (iii) At least one of catarrh symptoms: runny nose or sneezing
* Onset of first symptoms of cold must have occurred within 48 hours of screening.
Exclusion Criteria:
* Pregnant or breast feeding women
* History of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic cough due to any condition other than a common cold or flu, as determined by the investigator
* Concurrent illness or medical history that is contraindicated or cautioned about in the drug label
* Anatomical factors causing nasal congestion
* Fever with body temperature \>38.5°C at baseline
* Have used any medication or herbal remedies to treat cold prior to screening (antibiotics in the last 7 days, antihistamines in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours)
* Any medication that has potential drug-drug interactions with study medications
* Known or suspected intolerance or hypersensitivity to the study materials
* Have a positive drug urine test or recent history (within the last 2 years) of alcohol or other substance abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02246166
Study Brief:
Protocol Section:
NCT02246166