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This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ectoin containing Lozenges | treatment with Ectoin containing lozenges |
| |
| Hyaluronic acid containing lozenges | treatment with hyaluronic acid containing lozenges |
| |
| Saline solution for gargling | Subjects in were requested to gargle with salt water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical devices | Device |
| ||
| traditional household remedy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pharyngitis symptom score evaluated by the physician | 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:
| day 1 and day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pharyngitis symptoms evaluated on 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:
| 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with viral pharyngitis
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Sonnemann, MD | HNO-Praxis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HNO-Praxis Elmshorn | Elmshorn | Elmshorn | 25337 | Germany | ||
| HNO-Praxis Mahlstedt |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Device |
|
| Change in patient´s General condition evaluated by the physician | day 1 and day 7 |
| Patient´s Evaluation of tolerability | Assessment of tolerability on a numeric scale (bad-0; very good-10) | 7 days |
| physician´s Evaluation of tolerability | Assessment of tolerability on a numeric scale (bad-0; very good-10) | day 7 |
| Change in number and type of adverse Events | Incidence of adverse Events and correlations with the therapy | 7 days |
| Berlin |
| 10452 |
| Germany |
| HNO-Praxis Möller | Lüneburg | 21335 | Germany |
| HNO-Praxis | Norderstedt | 22846 | Germany |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |