Efficacy and Safety of Iota-Carrageenan Nasal Spray 1.2 g/l (0.12 Percent) (Bisolviral) Versus Placebo Nasal Spray in the Early Treatment of Common Cold
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)
研究概览
简要总结
The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on cold symptoms. The effect of treatment on the duration of the cold and the patients viral load plus cytokine level indicating the inflammatory response will be analyzed.
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
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients consider that they are in an early stage of common cold with symptoms of no more than 48 hours duration
- •Symptom score of equal or more than 1 for for at least one of the symptoms sore throat, runny nose and blocked nose on a 0-3 verbal rating scale
- •Total symptom score of equal or less 9 for symptoms headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, and sneezing measured on a 0-3 verbal rating scale
- •Patients agree to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through day 10 (e.g. those containing zinc, Echinacea); use of a daily multivitamin is allowed.
排除标准
- •Known hypersensitivity or are allergic to any component of the test device
- •Clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease
- •Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
- •History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
- •Taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics
- •Common cold or flu like symptoms for more than 48 hours.
- •Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom scores (analgesics, nasal decongestants, cough medicines)
- •Current smoker (more than 10 cigarettes a day)
研究组 & 干预措施
Iota-Carrageenan nasal spray
Nasal spray 4 times a day over 4 to 10 days
干预措施: Iota-Carrageenan (Device)
Placebo
Nasal spray 4 times a day over 4 to 10 days
干预措施: Placebo (Device)
结局指标
主要结局
Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)
时间窗: Days 2, 3 and 4
The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms. Each common cold symptom was scored on a 4-point ordinal scale: * 0 = symptom not present * 1 = mild symptom (I can feel it but it has not disturbed or irritated me) * 2 = moderate symptom (symptom has disturbed and irritated me some of the time) * 3 = severe symptom (symptom has disturbed and irritated me most of the time) The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms).
次要结局
- Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)(Days 2, 3 and 4)
- Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)(Days 2, 3 and 4)
- Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)(Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10)
- Duration of the Cold(Baseline up to 10 days)
- Patient Overall Assessment of Efficacy(Day 10)