drugset / Trial / NCT01706484

Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis

NCT01706484 ↗

Phase 3 Completed 927 enrolled Bionorica SE
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The purpose of this trial is to determine whether 2 different dosages of a herbal extract (240 and 480 mg/day) are more effective than placebo in the treatment of patients with chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5 and Visit 6.

Timeline

Start
2012-09
Primary completion
2014-04
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject BNO 1016 Traditional medicine (herbal / TCM) 240 mg Oral
Subject BNO 1016 Traditional medicine (herbal / TCM) 480 mg Oral