Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

Bitop

Status: Completed

Conditions: Acute Viral Pharyngitis

Treatments: Device: Medical devices; Device: traditional household remedy

Study type: Observational

Funder types: Industry

Identifiers

NCT02669446

2016/EHT/NIS

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Ectoin containing Lozenges

Description:

treatment with Ectoin containing lozenges

Treatment:

Device: Medical devices

Hyaluronic acid containing lozenges

Description:

treatment with hyaluronic acid containing lozenges

Treatment:

Device: Medical devices

Saline solution for gargling

Description:

Subjects in were requested to gargle with salt water

Treatment:

Device: traditional household remedy