EUCTR2009-016682-28-DE进行中（未招募）不适用
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.Multi-centre, double-blind, placebo-controlled, randomised, parallel group study
Bionorica AG0 个研究点开始时间: 2009年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed informed consent and data protection declaration
- •2.Male and female outpatients aged =18 and = 75 years
- •3.Diagnosis of acute rhinosinusitis
- •-characterised by a major symptom score* (MSS) = 8 and =12 points
- •(range: mini-mum 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
- •*Out of the 5 main rhinosinusitis symptoms at least 3 must be present. Among these the presence of nasal con-gestion and facial pain / pressure is mandatory.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Chronic rhinosinusitis
- •2.Polyposis nasi
- •3.Cystic fibrosis
- •4.Anatomical deviations of the nasal septum that significantly impair nasal
- •and paranasal ventilation / airflow
- •5.Acute symptoms of a known allergic rhinitis
- •6.Patients with asthma who have a history of exacerbations within 30 days
- •prior to study inclusion
- •7.Known hypersensitivity to study medication or excipients
- •8.Underlying diseases leading to significant immune deficiency
- •9.Signs or symptoms of fulminant bacterial sinusitis (e.g. fever > 38.5 °C,
- •orbital complications, severe unilateral frontal headache or toothache)
- •10.Odontogenic sinusitis
- •11.Treatment with systemic or nasal antibiotics or nasal or systemic
- •corticosteroids (excluding inhaled corticosteroids for mild to moderate
- •persistent asthma) within the last 4 weeks prior to study inclusion
- •12.Treatment with decongestant preparations, analgesics (including systemic
- •NSAIDs, except Paracetamol), mucolytics / secretolytics, antihistamines, or
- •alternative medicine preparations for treatment of common cold like
- •symptoms or with immunomodulating properties within the last 7 days
- •prior to study inclusion
- •13.Patients requiring antibiotic treatment for any condition at study entry
- •14.Pregnancy or lactation
- •15.Severe diseases of liver or kidney
- •16.Severe somatopathic, neurological and / or psychiatric diseases
- •17.Malignant growth (actual, condition after carcinoma not longer than
- •5 years without relapse)
- •18.History of alcohol or drug abuse
- •19.Parallel participation in another study, participation in a study within less
- •than 6 weeks prior to study entry, or previous participation in this same
- •20.Known to be, or suspected of being unable to comply with the study
- •protocol (e.g. no permanent address, history of drug abuse, known to be
- •non-compliant or presenting an unstable psychiatric history)
- •21.Legal incapacity and / or other circumstances rendering the patient unable
- •to understand the nature, scope and possible impact of the study
- •22.Patients in custody by juridical or official order
- •23.Evidence of an uncooperative attitude
- •24.Patients who have difficulties in understanding the language (German) in
- •which the patient information is given
- •25.Patients who are members of the staff of the study centre, staff of the
- •sponsor or CRO, the investigator him- / herself or close relatives of the
- •investigator
研究者
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