Acute Viral Pharyngitis
Conditions
Keywords
non-interventional study, Ectoin, Lozenges, Pharyngitis
Brief summary
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
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.
Interventions
DEVICEEctoin Lozenges Honey Lemon
application of Ectoin Lozenges (EHT02) in accordance with the instructions for use
DEVICEHyaluronic Acid/Icelandic moss Lozenges
application of the lozenges in accordance with the instructions for use
Sponsors
Bitop AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pharyngitis symptom score evaluated by the physician | day 1 and day 7 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Saliva production evaluated by the physician | day 7 | Assessment on a continuous numeric scale (0-no, 10-yes) |
| Evaluation how efficient the treatment is judged by physician | day 7 | Assessment on a continuous numeric scale (0-bad, 10-very good) |
| Evaluation how efficient the treatment is judged by patient | 7 days | Assessment on a continuous numeric scale (0-bad, 10-very good) |
| Change in Pharyngitis Symptoms evaluated in patient's diaries | 7 days | 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 |
| Evaluation how treatment is tolerated (judged by patients) | 7 days | Assessment on a continuous numeric scale (0-bad, 10-very good) |
| Evaluation of compliance evaluated by physician | day 7 | Assessment on a continuous numeric scale (0-bad, 10-very good) |
| Incidence of adverse events/serious adverse events | 7 days | All occuring adverse events/serious adverse events will be documented during the entire study period. |
| Evaluation how treatment is tolerated (judged by physician) | day 7 | Assessment on a continuous numeric scale (0-bad, 10-very good) |
Countries
Germany
Outcome results
None listed