NCT02746042

Sinupret Extract Coated Tablets in Chronic Rhinosinusitis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Assess Efficacy and Safety of the Herbal Medicinal Product Sinupret Extract Coated Tablets in Patients With Chronic Rhinosinusitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 572 (actual)
• Sponsor: Bionorica SE · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in the treatment of chronic rhinosinusitis (CRS) in adults.

Detailed description

The aim of the present double-blind, placebo-controlled, parallel-group, randomized, phase III clinical trial is to assess the efficacy, safety, and tolerability of Sinupret extract (3 x 160 mg = 480 mg daily) taken for up to 16-weeks compared with placebo in the treatment of chronic rhinosinusitis (CRS) in adults. In addition, in an exploratory approach to identify potential pharmacological modes of action underlying the expected treatment benefit, the anti-inflammatory activity of Sinupret extract will be assessed in a subset of CRS patients.

Conditions

• Chronic Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Sinupret extract coated tablets	1 coated tablet 3 times a day for 16-weeks (1-1-1)
DRUG	Placebo coated tablets	1 coated tablet 3 times a day for 16-weeks (1-1-1)

Timeline

• Start date: 2016-04-28
• Primary completion: 2017-07-26
• Completion: 2017-08-23
• First posted: 2016-04-21
• Last updated: 2018-02-28

Locations

45 sites across 2 countries: Germany, Poland