Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats

• Status: Completed
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

Summary

Aim of this study is to investigate safety and efficacy of A. Vogel Sore throat lozenges for the treatment of of acute sore throats

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: A. Vogel AG; Bioforce AG
• Treatments: Menthol

Criteria

Inclusion Criteria:

• Men and women aged 12-75 years

• Acute pharyngitis or tonsillitis with the following symptoms: Sore throat, Inflammation of the pharynx and/or tonsils

• Start of painful disease with the last 48 hours before study inclusion

• Tonsillopharyngitis Score bigger than or equal to 6 (s.attachment)

• Willingness to give blood samples and three viral throat swabs

• Written informed consent

Exclusion Criteria:

• Pharyngitis or tonsillitis more than 48 hours before study start (inclusion)

• Intake of analgetically active medication within the last 12 hours prior to study start (inclusion)

• Use of local sore throat medications within the last 4 hours prior to study start (inclusion)

• Patients with symptoms of a primary bacterial pharyngitis or a bacterial superinfection

• Severe medical condition (tumors, uncontrolled hypertension, heart insufficiency, immunosuppressive diseases etc.)

• Systemic use of corticosteroids in the last month prior to study inclusion

• Allergies to substances used in the tablet

• Pregnancy or lactation

• Participation or inclusion in one or more clinical trials within the last 30 days