A Comparative, Randomized, Double Blind, Parallel Group, Placebo Controlled, Observational clinical trial study to Evaluate Efficacy and Safetyof Test Product Nasal spray containing VB-Gy (Glycerol)and HPC-Cyanidins(HPC + Essential oils) versus 0.9% NaCl saline solution spray as Placebo inpatients suffering from acute or chronic Rhino-sinusitis.â€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- VITROBIO
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Change in mean of overall major symptoms score (sum of all symptoms of rhinorrhea (anterior nasal
研究概览
简要总结
This will be a Comparative, Randomized, Double Blind, Parallel group, Placebo Controlled, observational clinical trial study. The study will begin with screening evaluation.
Rhino-sinusitis Severity Score
Rhino-sinusitis Severity Score will be calculated by sum of all symptoms (rhinorrhea (anterior nasal discharge), postnasal drip, nasal congestion, headache, facial pain/pressure) yielding a possible range of 0 to
50, with higher score reflecting greater symptom severity.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with complain of clinical manifestations of Rhino-sinusitis (RS) Major symptoms (rhinorrhea (anterior nasal discharge), postnasal drip, nasal congestion, headache, facial pain/pressure), with a minimum Rhino-sinusitis severity (RSS) score of 25 out of 50.
排除标准
- •Hypersensitivity to any of the Investigational product‟s components.
结局指标
主要结局
Change in mean of overall major symptoms score (sum of all symptoms of rhinorrhea (anterior nasal
时间窗: from baseline to 30 | minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery
discharge), postnasal drip, nasal congestion, headache, facial pain/pressure scores)
时间窗: from baseline to 30 | minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery
次要结局
- Proportion of patients requiring antibiotics in Test group as compared to placebo group.(from baseline to 30)
- Change in individual symptoms score of rhinorrhea (anterior nasal discharge), postnasal drip, nasal(congestion, headache, facial pain/pressure scores) from baseline to 30 minute post 1st dose initiation on)