Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.

Study Overview
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Brief Summary
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The goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.

Detailed Description
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The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin Lozenges Honey Lemon in patients suffering from acute viral pharyngitis. Participants receive treatments as part of routine medical care, and participants can choose one of two treatment options: a) Ectoin Lozenges Honey Lemon or b) lozenges containing hyaluronic acid and icelandic moss. Efficacy will be studied by documentation of the following symptoms: pain on swallowing hoarseness urge to cough dry mouth and throat redness of oropharynx and larynx sore throat impairment of free breathing general feeling of illness In parallel, participating patients will document their symptoms over the entire study duration in patient diaries. The observation takes place over a period of seven days.

Official Title
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Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.

Conditions
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Acute Viral Pharyngitis

Intervention / Treatment
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* Device: Ectoin Lozenges Honey Lemon
* Device: Hyaluronic Acid/Icelandic moss Lozenges


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with acute viral pharyngitis Exclusion Criteria: patients with known intolerance to one of the substances used Pregnancy Surgical Procedures in the mouth and throat region prior to the study Bacterial Pharyngitis symptoms in the throat since more than 5 days Contraindications according to the instructions for use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ectoin Lozenges Honey Lemon<br>application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day | Device: Ectoin Lozenges Honey Lemon<br>* application of Ectoin Lozenges (EHT02) in accordance with the instructions for use<br>* Other names: EHT02;|
| Hyaluronic acid/Icelandic moss Lozenges<br>application as often as required, not more than 6 lozenges per day | Device: Hyaluronic Acid/Icelandic moss Lozenges<br>* application of the lozenges in accordance with the instructions for use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pharyngitis symptom score evaluated by the physician | The intensity of the symptoms will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: pain on swallowing hoarseness urge to cough dry mouth and throat reddening of oropharynx reddening of larynx sore throat impairment of free breathing patient's general condition | day 1 and day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pharyngitis Symptoms evaluated in patient's diaries | The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: pain on swallowing hoarseness urge to cough dry mouth and throat sore throat impairment of free breathing patient's general condition | 7 days | 
| Change of Saliva production evaluated by the physician | Assessment on a continuous numeric scale (0-no, 10-yes) | day 7 | 
| Evaluation how efficient the treatment is judged by physician | Assessment on a continuous numeric scale (0-bad, 10-very good) | day 7 | 
| Evaluation how efficient the treatment is judged by patient | Assessment on a continuous numeric scale (0-bad, 10-very good) | 7 days | 
| Evaluation how treatment is tolerated (judged by physician) | Assessment on a continuous numeric scale (0-bad, 10-very good) | day 7 | 
| Evaluation how treatment is tolerated (judged by patients) | Assessment on a continuous numeric scale (0-bad, 10-very good) | 7 days | 
| Evaluation of compliance evaluated by physician | Assessment on a continuous numeric scale (0-bad, 10-very good) | day 7 | 
| Incidence of adverse events/serious adverse events | All occuring adverse events/serious adverse events will be documented during the entire study period. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-interventional study, Ectoin, Lozenges, Pharyngitis