Randomized,Double-blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of the Phytotherapic Compound "Bromelin" on Acute Irritative Cough
试验速览
- 阶段
- 4 期
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in score in a cough evaluation questionnaire
研究概览
简要总结
Cough is the most bothersome symptom for patients with the common cold.
The objective of the study is to compare the phytotherapic "Bromelin", a compound preparation of honey from the bee apis mellifera with the extract of the pineapple (Ananas comosus) with placebo in reducing cough episodes in patients with the common cold.
详细描述
Common cold is very frequent and cough is one of the most troublesome symptoms. Over-the-counter medications are used by patients without prescription, many times with important side effects.
Bromelin, a compound made with honey and pineapple extract could offer cough symptomatic relief as a soothing agent.
This study aims to compare this compound with placebo in reducing cough in patients with common cold in an clinical trial designed in conformity to CONSORT guidelines.
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, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cough for less than 24 hours
- •common cold symptoms : nasal obstruction, headache, myalgias, runny nose.
排除标准
- •declared chronic pulmonary diseases declared Nervous diseases declared Diabetes declared cardiac diseases known primary or secondary immunodeficiencies
研究组 & 干预措施
Active drug
Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.
干预措施: Bromelin (Drug)
Placebo
Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in score in a cough evaluation questionnaire
时间窗: before and 10 and 30 minutes after the dosing
A cough score based on number of coughing episodes and subjective 5 item cough score : no cough, mild, moderate, severe, very severe.
次要结局
- Change in Occurrence of gastric symptoms(10 and 30 minutes)