At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 386 enrolled
Drug / intervention
BNO 1016 +1 moredrug
Likely dose
BNO 1016 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-centre, Double-blind, Placebo-controlled, Randomised, Parallel Group Study to Assess the Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
In Brief
A Phase 3 clinical trial evaluating BNO 1016 and Placebo for Acute Rhinosinusitis. Completed, enrolled 386 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Rhinosinusitis
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
Primary CompletionApr 2010
First PostedJun 2010
TodayJul 2026
First PostedJun 22, 2010
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.0 years ago
Interventions
BNO 1016drug
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
Placebodrug
sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days