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.