Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.

Bitop

Status: Completed

Conditions: Acute Viral Pharyngitis

Treatments: Device: Ectoin Lozenges Honey Lemon; Device: Hyaluronic Acid/Icelandic moss Lozenges

Study type: Observational

Funder types: Industry

Identifiers

NCT03943186

btph-014-2018-EHT02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

102 participants in 2 patient groups

Ectoin Lozenges Honey Lemon

Description:

application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day

Treatment:

Device: Ectoin Lozenges Honey Lemon

Hyaluronic acid/Icelandic moss Lozenges

Description:

application as often as required, not more than 6 lozenges per day

Treatment:

Device: Hyaluronic Acid/Icelandic moss Lozenges