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

NCT ID: NCT01146860

Last Updated: 2013-08-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Acute Rhinosinusitis

Keywords

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BNO 1016, acute rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

BNO 1016

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Sinupret extract Placebo to BNO 1016

Eligibility Criteria

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Inclusion Criteria

Diagnosis of acute rhinosinusitis

* characterized by a major symptom score (MSS) ≥ 8 and ≤ 12 points (minimum 0, maximum 15 points)
* individual score for facial pain/pressure ≥ 1 (mild) and ≤ 2 (moderate)
* confirmed by ultrasonography of paranasal sinuses
* with presence of symptoms ≤ 3 days prior to inclusion

Exclusion Criteria

* Chronic rhinosinusitis
* Polyposis nasi
* Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow
* Acute symptoms of a known allergic rhinitis
* Patients with asthma who have a history of exacerbations within 30 days prior to study inclusion
* Signs or symptoms of fulminant bacterial sinusitis
* Odontogenic sinusitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bionorica SE

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rainer Jund, MD

Role: STUDY_CHAIR

Specialist in Otorhinolaryngology

Locations

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Dr. Rainer Jund, Specialist in Otorhinolaryngology

Puchheim, , Germany

Site Status

Countries

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Germany

References

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Jund R, Mondigler M, Steindl H, Stammer H, Stierna P, Bachert C; ARhiSi II study group. Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis. Rhinology. 2012 Dec;50(4):417-26. doi: 10.4193/Rhino.12.015.

Reference Type DERIVED
PMID: 23193534 (View on PubMed)

Other Identifiers

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2009-016682-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARhiSi-2

Identifier Type: -

Identifier Source: org_study_id