Randomized, Single-center, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Tolerability of ABO/MEG-B-09 in Pediatric Cough
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Cough score variation
研究概览
简要总结
The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute cough as compared to a placebo syrup.
详细描述
Subjects will be asked to take 4 doses of 5 ml containing a mixture of honey and other natural ingredients or a placebo syrup everyday, during 8 days. The following outcomes will be noted down in a diary: occurence and severity of diurnal and nocturnal cough events (cough score) and symptoms, impediment of normal life activities (school, sleeping), the number of medical visits and type of medication needed if any.
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 3 and 6
- •Acute cough - lasting 1-3 weeks
- •Written informed consent by the parents/legal tutors
- •Parents/legal tutors must be willing not to give to the child other medications or products for the treatment of cough during the study period, unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study
- •Parents/legal tutors must be willing to comply with the study protocol
排除标准
- •Children treated with immunostimulators and immune regulating drugs during the last month before starting the study
- •Children with immunodeficiencies or immune suppression
- •Children with chronic diseases - Pulmonary Diseases, Renal insufficiency, Heart diseases
- •Children treated with antibiotics, including prophylactic treatment
- •Children being treated with systemic corticosteroids - including oral aerosol inhaler
- •Children with potential immunosuppressive viral diseases - Measles, Chickenpox, Rubella, Infectious mononucleosis - within the last month
- •Children who have participated in previous studies with experimental products within the last month
- •Children with asthma or suspected diagnosis of asthma
- •Children with bacterial diseases - Pneumonia, Sepsis
- •Children with diabetes because of the high content of sugar of the study products - ABO/MEG-B-09 and placebo
- •Children allergic to any study product ingredients
- •Children/Parents/legal tutors with psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study protocol - syrup administration or compilation of the diary
研究组 & 干预措施
AboMeg-B-09 syrup
Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
干预措施: AboMeg-B-09 (Device)
Placebo
Placebo syrup
干预措施: Placebo (Other)
结局指标
主要结局
Cough score variation
时间窗: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Clinical diurnal and nocturnal cough score (Chung)
次要结局
- Cough reflex sensitivity(Measured at Baseline Visit (day 0) and at the Last Visit (day 8))
- The ventilation of the various pulmonary zones(Measured at Baseline Visit (day 0) and at the Last Visit (day 8))
- Quality of life(Measured at Baseline Visit (day 0) and at the Last Visit (day 8))
- Objective breath sounds(Measured at Baseline Visit (day 0) and at the Last Visit (day 8))