Overview

Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray Compared to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of treatment. Main outcome parameter is the non-inferiority in number of responders between the two treatment groups. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start. The symptoms are assessed with a symptom score.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
A. Vogel AG
Bioforce AG
Treatments:
Chlorhexidine
Chlorhexidine gluconate
Lidocaine
Criteria
Inclusion Criteria:

- Age > 12 years;

- Acute pharyngitis or tonsillitis with symptoms of throat pain and inflammation of the
pharynx and/or tonsils;

- Onset of sore throat less than 72 hours before inclusion ;

- A Tonsillopharyngitis Severity Score ≥6;

- Written informed consent.

Exclusion Criteria:

- Analgesics <12 hours;

- Antibiotics <24 hours; t

- Topical throat pain medication <4 hours;

- Systemic corticosteroids within the last month;

- Symptoms of primary bacterial pharyngitis or secondary bacterial infection;

- Serious illness such as tumors; allergy to one of the ingredients; pregnancy or
lactation;

- Hypersensitivity to ibuprofen;

- Participation in another clinical trial in the previous 30 days.