Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold symptoms.
详细描述
Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.
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)
盲法说明
Double blind study
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain;
- •Signed Consent of the patient;
- •Participant whose tutors have the capacity to understand and consent to the child's participation in the clinical study, manifested by signing TCLE
排除标准
- •Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
- •Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
- •Patients with history of hypersensitivity to any of the formula compounds;
- •Participation in clinical trial in the year prior to this study;
- •Patients with vaccine reaction;
- •Patients who have uncontrolled asthma however, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma;
- •Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract;
- •Patients with diabetes mellitus type I and II;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Patients who were in use of drugs that can interfere with flu symptoms evaluation.
研究组 & 干预措施
Irlanda-1-Association
For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
干预措施: Irlanda-1-Association (Drug)
Placebo
For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
干预措施: Placebo (Drug)
结局指标
主要结局
Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.
时间窗: 7 days
次要结局
- Safety will be evaluated by the adverse events occurrences(7 days)