Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis

Overview

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

• Device HMG
  Patients included in the "HMG" arm will receive the medical device of the same name.
• Device PHN
  Patients included in the "PHN" arm will receive the medical device of the same name.
• Device PHR
  Patients included in the "PHR" arm will receive the medical device of the same name.
• Device TUR
  Patients included in the "TUR" arm will receive the medical device of the same name.

Primary outcome measures

• Tolerance [Time frame: From visit 1 (day 1) to visit 2 (day 8)]

Secondary outcome measures (4)

• Efficiency [Time frame: From visit 1 (day 1) to the last day of use of the study product (day 8)]
• Efficiency [Time frame: From visite 1 (day 1) to visit 2 (day 8)]
• Quality of life impact [Time frame: From visite 1 (day 1) to visit 2 (day 8)]
• Device defect [Time frame: From visit A (day 1) to visit 2 (day 8)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Chu Clermont Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07569939 · RBHP 2026 PICKERING (PharyTol) · 2026-A00430-51

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗