Status:
COMPLETED
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
Lead Sponsor:
A. Vogel AG
Conditions:
Pharyngitis
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief 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 outcom...
Detailed Description
Further secondary parameters are : Responders during at day 4 and 5, single symptom scores during 1 to 5 days of observation, pain at begin and end (100mm VAS), assessment of efficacy by physician an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00707902
Start Date
February 1 2006
End Date
August 1 2006
Last Update
July 1 2008
Active Locations (1)
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1
Allergy Clinic
Landquart, Switzerland, 7302