NCT02396706已完成2 期
Randomized, Controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of a Liquid Containing Ivy Leaves Dry Extract vs. Placebo in the Treatment of Acute Cough
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute cough with symptoms lasting 2-3 days prior to treatment
- •Men or women of any ethnic origin
- •Age 18 to 75 years
- •Subjects who are able to understand and are willing to comply to trial instructions
- •Having given written informed consent
- •Satisfactory health except for the cough as determined by the investigator based on medical history and physical examination
- •CS score of at least 50 mm on a 100 mm VAS at V1
- •Acute BSS of at least 10 points at V1
- •VCD score of at least 2 points at V1
排除标准
- •Allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease
- •History of hypersensitivity to any excipient of the applied drugs
- •History of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever
- •History of chronic gastritis or peptic ulcers
- •Any gastrointestinal complaints within 7 days before V1
- •Participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly
- •Treatment with corticoids, beta-2 agonists (e.g. salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, angiotensin-converting enzyme (ACE) inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate or homeopathic drugs against common cold within 7 days before V1
- •Drug or alcohol abuse in the opinion of the investigator
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception.
- •Subjects with significant diseases, defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject's ability to participate in the trial; includes subjects with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease.
- •Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them.
研究组 & 干预措施
Ivy Leaves Cough Liquid
Active Comparator
Ivy Leaves Cough Liquid
干预措施: Ivy Leaves Cough Liquid (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: whole treatment period over 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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