Acute Pharyngitis, Viral Sore Throat
Conditions
Brief summary
The objective of this study is to conduct post-marketing clinical follow-up of four products: HMG, PHN, PHR, and TUR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of sore throats related to acute pharyngitis and/or viral-origin tonsillitis, while also assessing the benefit/risk ratio of the products.
Interventions
DEVICEHMG
Patients included in the "HMG" arm will receive the medical device of the same name.
DEVICEPHN
Patients included in the "PHN" arm will receive the medical device of the same name.
DEVICEPHR
Patients included in the "PHR" arm will receive the medical device of the same name.
DEVICETUR
Patients included in the "TUR" arm will receive the medical device of the same name.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pharyngitis or tonsillitis or acute nasopharyngitis or viral-origin sore throat with odynophagia that began less than 72 hours before the inclusion visit according to the investigator's judgment * Bacterial rhinopharyngitis with negative TROD test * Effective contraception for female patients of childbearing age * Cooperation and sufficient understanding to comply with the requirements of the trial * Acceptance of registration in the SI-RIPH database * Having received informed information and agreeing to give written consent * Affiliated with the French Social Security scheme.
Exclusion criteria
* Hypersensitivity/previous allergy to any of the product components, * Pharyngitis or tonsillitis or acute rhinopharyngitis complicated (phlegmon, acute otitis media, pneumonia…) or severely intolerable cough, * Positive antigen test for influenza A/B or COVID-19 and infection requiring etiological treatment according to the recommendations, * Other ongoing treatments for acute pharyngitis or tonsillitis (local treatment, antibiotics, corticosteroids, antiretroviral…), * Comorbidities or health conditions deemed incompatible with the trial by the investigator, * Recent otorhinolaryngology surgery (\<6 months), * Pulmonary pathology (Chronic Obstructive Pulmonary Disease, asthma…), * Immunosuppression (according to patient's report), * Pregnant or breastfeeding women, * Currently participating in another clinical trial, or in the exclusion period, or having received total compensation of more than €6,000 in the 12 months prior to the start of the trial, * Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | From visit 1 (day 1) to visit 2 (day 8) | Collection of adverse events (AEs) during the period of use of HMG, PHN, PHR, TUR products in an electronic daily recording book |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency | From visit 1 (day 1) to the last day of use of the study product (day 8) | Clinical improvement (yes/no) defined as a decrease of at least 30% in the "total score for symptoms of sore throats" (STSMG) between baseline and the average of the scores measured during the last 3 days of use of the study product (days 5,6,7). |
| Quality of life impact | From visite 1 (day 1) to visit 2 (day 8) | Change in quality of life measured by four questions before (Day 1) and after (Day 8) use of the study products concerning sleep, daily activities, fatigue, and irritability. Each response will be rated between 0 (not impacted) and 10 (highly impacted) on a visual analog scale. |
| Device defect | From visit A (day 1) to visit 2 (day 8) | Device defect assessed by recording any defect in terms of identity, quality, durability, reliability, safety, or performance, malfunction, or user error, or any defect in the information provided by the manufacturer in the electronic record book. |
Countries
France
Contacts
CONTACTLise Laclautre
Outcome results
None listed