Multicentric Randomized Double Blind Double Dummy Placebo Controlled Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray in Comparison to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- A. Vogel AG
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- comparison of responder of the two treatment groups after the first, second, and third days. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start.
研究概览
简要总结
The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of treatment.
Main outcome parameter is the non-inferiority in number of responders between the two treatment groups. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start. The symptoms are assessed with a symptom score.
详细描述
Further secondary parameters are :
Responders during at day 4 and 5, single symptom scores during 1 to 5 days of observation, pain at begin and end (100mm VAS), assessment of efficacy by physician and patient, consumption of rescue medication
Assessment of safety by physician and patient, frequency of adverse events
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 12 years;
- •Acute pharyngitis or tonsillitis with symptoms of throat pain and inflammation of the pharynx and/or tonsils;
- •Onset of sore throat less than 72 hours before inclusion ;
- •A Tonsillopharyngitis Severity Score ≥6;
- •Written informed consent.
排除标准
- •Analgesics <12 hours;
- •Antibiotics <24 hours; t
- •Topical throat pain medication <4 hours;
- •Systemic corticosteroids within the last month;
- •Symptoms of primary bacterial pharyngitis or secondary bacterial infection;
- •Serious illness such as tumors; allergy to one of the ingredients; pregnancy or lactation;
- •Hypersensitivity to ibuprofen;
- •Participation in another clinical trial in the previous 30 days.
研究组 & 干预措施
2
Drug: Echinacea/sage
patients received additionally a placebo-spray for the synthetical comparator (chlorhexidine/lidocaine) as the study was double dummy blinded.
Patients had to apply spray every 2 hours with two puffs to the pharyngeal area up to a maximum of 10 times daily. Treatment duration was until illness was resolved or for a maximum of 5 consecutive days.
Arms: 1
干预措施: echinacea/sage (Drug)
1
Drug: Chlorhexidine/lidocaine
patients received additionally a placebo-spray for the synthetical comparator (echinacea/sage) as the study was double dummy blinded.
Patients had to apply spray every 2 hours with two puffs to the pharyngeal area up to a maximum of 10 times daily. Treatment duration was until illness was resolved or for a maximum of 5 consecutive days.
干预措施: chlorhexidine/lidocaine (Drug)
结局指标
主要结局
comparison of responder of the two treatment groups after the first, second, and third days. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start.
时间窗: first three days of treatment
次要结局
- Comparison of response rates after 4th and 5th days of treatment; VAS throat pain; amount rescue medication used; global assessment efficacy Frequency of adverse events, global assessment of tolerability(five days of treatment)