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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03369132
Eligibility Criteria:
Inclusion Criteria:
* 1\. Adults (male or female) aged ≥ 18 years old.
* 2\. Patients with complaint of sore throat ≤ 72h.
* 3\. Sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis).
* 4\. Clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis.
* 5\. Pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate.
* 6\. Willingness to provide written informed consent prior to perform of any study related procedure.
* 7\. Subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements).
* 8\. Subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity).
* 9\. Subject affiliated to social security.
* 10\. Subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself.
Exclusion Criteria:
* 1\. Previous history of allergy or known intolerance to one of the following formulation ingredients: seawater, vegetable glycerin, mint, lemon, acacia honey, propolis, essential oils.
* 2\. Active Smokers.
* 3\. Fever \> 38°C at randomization.
* 4\. Past or current throat phlegmon.
* 5\. Past or current seasonal allergy.
* 6\. Past or current asthma.
* 7\. Past or current chronic rhinosinusitis.
* 8\. Past or current chronic obstructive pulmonary disease (COPD).
* 9\. Past or current ENT (Ear, Nose and Throat) cancer.
* 10\. Acute rhinosinusitis.
* 11\. Controlled or uncontrolled diabetes.
* 12\. Gastroesophageal reflux disease (GERD).
* 13\. Known immunodeficiency.
* 14\. Any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage.
* 15\. Any disease that may interfere with the study aim from investigator's opinion.
* 16\. Evidence of mouth breathing or severe coughing.
* 17\. Patient with severe pain intensity on 5-point descriptive pain intensity scale.
* 18\. Subjects taking:
* chronic treatment for throat or other ENT pathology,
* current antibiotherapy or stopped less than 2 weeks before inclusion,
* chronic treatment (\>3 months) with local or systemic corticotherapy, or immunotherapy,
* local or systemic antihistaminic.
* 19\. Subjects refusing to stop at entry into the study:
* throat spray, lozenge, pastille,
* local throat or systemic analgesic,
* medicated confectionary,
* nasal wash and spray,
* nasal corticosteroid or antihistaminic nasal spray,
* medication to gargle,
* honey, propolis, or any sore throat home remedies.
* 20\. Known liver disease or hypersensitivity to paracetamol.
* 21\. Pregnant, breastfeeding or seeking pregnancy women.
* 22\. Positive result from rapid strep throat test.
* 23\. Subjects already included once in this study.
* 24\. Subjects participating in another clinical trial or in the exclusion period to another study.
* 25\. Subjects having a member of his/her home who is currently participating to this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03369132
Study Brief:
Protocol Section:
NCT03369132