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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ectoin Lozenges Honey Lemon | application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day |
| |
| Hyaluronic acid/Icelandic moss Lozenges | application as often as required, not more than 6 lozenges per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ectoin Lozenges Honey Lemon | Device | application of Ectoin Lozenges (EHT02) in accordance with the instructions for use |
|
| 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:
| day 1 and day 7 |
| 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:
| 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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patients diagnosed with acute viral pharyngitis
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Bilstein, Dr | CSO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| bitop AG | Dortmund | 44263 | Germany |
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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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| Hyaluronic Acid/Icelandic moss Lozenges | Device | application of the lozenges in accordance with the instructions for use |
|
| 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 |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |