Status:
COMPLETED
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
Lead Sponsor:
Bionorica SE
Conditions:
Acute Rhinosinusitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.
Detailed Description
The aim of this clinical study is to investigate the efficacy of a 15-days treatment with the herbal medicinal product BNO 1016 for therapy of acute rhinosinusitis in adult patients. Due to the consid...
Eligibility Criteria
Inclusion
- Diagnosis of acute rhinosinusitis
- characterized by a major symptom score (MSS) ≥ 8 and ≤ 12 points (minimum 0, maximum 15 points)
- individual score for facial pain/pressure ≥ 1 (mild) and ≤ 2 (moderate)
- confirmed by ultrasonography of paranasal sinuses
- with presence of symptoms ≤ 3 days prior to inclusion
Exclusion
- Chronic rhinosinusitis
- Polyposis nasi
- Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow
- Acute symptoms of a known allergic rhinitis
- Patients with asthma who have a history of exacerbations within 30 days prior to study inclusion
- Signs or symptoms of fulminant bacterial sinusitis
- Odontogenic sinusitis
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT01146860
Start Date
January 1 2010
End Date
April 1 2010
Last Update
August 2 2013
Active Locations (1)
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1
Dr. Rainer Jund, Specialist in Otorhinolaryngology
Puchheim, Germany, 82178