Acute Viral Pharyngitis
Conditions
Keywords
Non interventional study, Ectoin, Lozenges, pharyngitis
Brief summary
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.
Interventions
DEVICEMedical devices
DEVICEtraditional household remedy
Sponsors
Bitop AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with acute Pharyngitis according to instruction for use * Female or male individuals ≥ 18 years * Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist)
Exclusion criteria
* Contraindications according to instructions for use * Male or female person under 18 years * Sore throat for more than 5 days * Any disease that can, in the opinion of the treating physician to affect the outcome of the study. * Patients with known intolerance to one of the substances used * Surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the NIS * Bacterial Pharyngitis * Pregnancy
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 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 * tickle in the throat * hoarseness * dry mouth and throat * burning of throat * patient´s General condition * reddening of the oropharynx * reddening of the larynx |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pharyngitis symptoms evaluated on 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 * tickle in the throat * hoarseness * dry mouth and throat * burning of throat * patient´s General condition |
| Change in patient´s General condition evaluated by the physician | day 1 and day 7 | — |
| Patient´s Evaluation of tolerability | 7 days | Assessment of tolerability on a numeric scale (bad-0; very good-10) |
| physician´s Evaluation of tolerability | day 7 | Assessment of tolerability on a numeric scale (bad-0; very good-10) |
| Change in number and type of adverse Events | 7 days | Incidence of adverse Events and correlations with the therapy |
Countries
Germany
Outcome results
None listed