A Multi-centre, Double-blind, Placebo-controlled, Randomised, Parallel Group Study to Assess the Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bionorica SE
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Major Symptom Score (MSS) Assessed by the Investigator
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: BNO 1016 (Drug)
Placebo
sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days
干预措施: Placebo (Drug)
结局指标
主要结局
Major Symptom Score (MSS) Assessed by the Investigator
时间窗: 14 days
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.
次要结局
- SNOT 20 Symptom Scores(14 days)
- Major Symptom Score Assessed by the Patient(14 days)
- Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale(14 days)
- Ultrasonography of Paranasal Sinuses(14 days)