Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats (NCT04139681) | Clinical Trial Compass
CompletedPhase 4
Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats
Bulgaria74 participantsStarted 2019-03-12
Plain-language 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
Who can participate
Age range12 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" tolerability ratings as assessment by a physician