Acute PharyngitisPharyTolNCT07569939
Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis
A study testing HMG, PHN and PHR in people with Acute Pharyngitis and Viral Sore Throat, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pharyngitis, Viral Sore Throat
- What is being tested?
- HMG, PHN and PHR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Gisèle PICKERING
About this study
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.
- Conditions
- Acute Pharyngitis, Viral Sore Throat
- Being tested
- HMG, PHN, PHR, TUR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMGDevice
Patients included in the "HMG" arm will receive the medical device of the same name.
PHNDevice
Patients included in the "PHN" arm will receive the medical device of the same name.
PHRDevice
Patients included in the "PHR" arm will receive the medical device of the same name.
TURDevice
Patients included in the "TUR" arm will receive the medical device of the same name.
| Study group | Role | What they receive |
|---|---|---|
| HMG | Experimental | Patients included in the "HMG" arm will receive the medical device of the same name. Receives: Device: HMG |
| PHN | Experimental | Patients included in the "PHN" arm will receive the medical device of the same name. Receives: Device: PHN |
| PHR | Experimental | Patients included in the "PHR" arm will receive the medical device of the same name. Receives: Device: PHR |
| TUR | Experimental | Patients included in the "TUR" arm will receive the medical device of the same name. Receives: Device: TUR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
Collection of adverse events (AEs) during the period of use of HMG, PHN, PHR, TUR products in an electronic daily recording book
Measured: From visit 1 (day 1) to visit 2 (day 8)
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From visit A (day 1) to visit 2 (day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start29 Jul 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PharyngitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569939
- Sponsor's protocol ID
- RBHP 2026 PICKERING (PharyTol)
- Other IDs
- 2026-A00430-51
- Acronym
- PharyTol
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis
- ClinicalTrials.gov ID
- NCT07569939
- Acronym / sponsor ID
- PharyTol / RBHP 2026 PICKERING (PharyTol)
- Conditions
- Acute Pharyngitis, Viral Sore Throat
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HMG | Experimental | Device: HMGPatients included in the "HMG" arm will receive the medical device of the same name. |
| PHN | Experimental | Device: PHNPatients included in the "PHN" arm will receive the medical device of the same name. |
| PHR | Experimental | Device: PHRPatients included in the "PHR" arm will receive the medical device of the same name. |
| TUR | Experimental | Device: TURPatients included in the "TUR" arm will receive the medical device of the same name. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMGPatients included in the "HMG" arm will receive the medical device of the same name. | Device | HMG |
| PHNPatients included in the "PHN" arm will receive the medical device of the same name. | Device | PHN |
| PHRPatients included in the "PHR" arm will receive the medical device of the same name. | Device | PHR |
| TURPatients included in the "TUR" arm will receive the medical device of the same name. | Device | TUR |
Primary outcome
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
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMG, PHN and PHR in people with Acute Pharyngitis and Viral Sore Throat, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance (time frame: From visit 1 (day 1) to visit 2 (day 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.