Conditions: Acute Rhinosinusitis
Keywords: BNO 1016, acute rhinosinusitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 386
Healthy volunteers: no

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 considerable morbidity and the diminished quality of life experienced by people afflicted with acute rhinosinusitis an important aim of the treatment is to reduce the severity of rhinosinusitis symptoms and the duration of the disease. By grading the severity of the disease on the basis of the 5 main rhinosinusitis symptoms the investigator will assess the efficacy of the treatment.

Arms:
arm 1: sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days arm 2: sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days

Interventions: intervention 1: BNO 1016 intervention 2: Placebo
Intervention descriptions: intervention 1: sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days intervention 2: sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days

Protocol document: