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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
160
Chu Clermont Ferrand
Clermont-Ferrand, France
Tolerance
Collection of adverse events (AEs) during the period of use of HMG, PHN, PHR, TUR products in an electronic daily recording book
Time frame: From visit 1 (day 1) to visit 2 (day 8)
Efficiency
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).
Time frame: From visit 1 (day 1) to the last day of use of the study product (day 8)
Efficiency
Clinical improvement (yes/no) at the medical examination: the assessment of pharyngeal erythema and general signs (lymphadenopathy, fever) by comparing the patient's data at inclusion and during the visit on day 8.
Time frame: From visite 1 (day 1) to visit 2 (day 8)
Quality of life impact
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.
Time frame: From visite 1 (day 1) to visit 2 (day 8)
Device defect
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.
Time frame: From visit A (day 1) to visit 2 (day 8)
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Patients included in the "TUR" arm will receive the medical device of the same name.