EUCTR2008-002794-13-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 two different dosages of a herbal medicinal product (dry extract BNO-1016) in patients with acutre rhinosinusitisMulti-centre, double-blind, placebo-controlled, randomised, parallel group study
Bionorica AG0 个研究点开始时间: 2008年12月17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 including data protection declaration
- •2. Male and female outpatients aged =18 and = 75 years
- •3. Diagnosis of acute rhinosinusitis - characterized by a major symptom score* (MSS) =8 points (minimum 0, maximum 15 points) - 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 congestion 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 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 (except Paracetamol), mucolytics / secretolytics, antihistamines, or alternative medicine preparations for treatment of common coldlike 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 study
- •20. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known 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
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