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Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis

NCT01146860 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2013-08-02

Study results available
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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.

Conditions

  • Acute Rhinosinusitis

Interventions

DRUG

BNO 1016

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

DRUG

Placebo

sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days

Sponsors & Collaborators

  • Bionorica SE

    lead INDUSTRY

Principal Investigators

  • Rainer Jund, MD · Specialist in Otorhinolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01146860 on ClinicalTrials.gov