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

May 6, 2026 updated by: University Hospital, Clermont-Ferrand
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HMG
Patients included in the "HMG" arm will receive the medical device of the same name.
Device: HMG
Patients included in the "HMG" arm will receive the medical device of the same name.
Experimental: PHN
Patients included in the "PHN" 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.
Experimental: PHR
Patients included in the "PHR" 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.
Experimental: TUR
Patients included in the "TUR" 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance
Time Frame: 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
From visit 1 (day 1) to visit 2 (day 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency
Time Frame: 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).
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)
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.
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)
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.
From visite 1 (day 1) to visit 2 (day 8)
Device defect
Time Frame: 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.
From visit A (day 1) to visit 2 (day 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2026 PICKERING (PharyTol)
  • 2026-A00430-51 (Other Identifier: 2026-A00430-51)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Pharyngitis

Clinical Trials on HMG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe