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

Bionorica SE386 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

386

Conditions

Acute Rhinosinusitis

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr. Rainer Jund, Specialist in Otorhinolaryngology

Puchheim, Germany

Outcomes

Primary Outcomes

Major Symptom Score (MSS) Assessed by the Investigator

MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure. Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe. Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points.

Time frame: 14 days

Secondary Outcomes

SNOT 20 Symptom Scores

Sino-Nasal Outcome Test (SNOT 20): 20 item questionnaire to assess the symptoms and emotional and social consequences of rhinosinusitis. The symptoms are assessed by the patient using a 6-point rating scale: 0 = not present / no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as "bad as it can be". range: 0 to 100

Time frame: 14 days

Major Symptom Score Assessed by the Patient

Time frame: 14 days

Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale

General assessment of efficacy using a 4-point rating scale (symptoms healed, improved, unchanged, deteriorated). Patients whose symptoms are improved or healed will be classified as "responders" to treatment. Patients whose symptoms are unchanged or deteriorated as classified as "non-responders".

Time frame: 14 days

Ultrasonography of Paranasal Sinuses

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.