A double blind, single centric, randomized placebo-controlled study to demonstrate the efficacy and tolerability of an oral product in the management of symptoms of cough in comparison to placebo.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Giellepi Spa
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To demonstrate that Investigational product is more effective than placebo for the management persisting cough. An improvement of 2 score (Cough Clinical Score) is expected in 25% of subjects treated with investigational product.
研究概览
简要总结
This clinical trial is being planned to assess the efficacy and safety of a new product when compared to placebo in the treatment of cough in adults. 40 subjects with cough will be recruited into the trial and the trial will be for a period of 10 days from the day of randomisation.
The treatment will observe the improvement in day time score with the help of questionnaire, change in Leicester cough questionnaire, Change in cough using VAS and change in nocturnal cough and sleep quality on Day 0, day 5 and day 10.
The objective of this study is to access the efficacy and safety of the investigational product in adult subjects with cough.
Type of the study - Randomized, double blind, placebo controlled
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient should be able to give written informed consent.
- •2.Diagnosis of persisting cough (Cough Clinical Score of 3) 3.Males and females, 18-65 years of age (both inclusive)
- •Ability to comply with requirements of trial.
- •4.Persisting cough (at least 7 days up to 3 weeks, not treated with any antitussive product).
排除标准
- •Subjects having TB, COPD or Asthma, pulmonary fibrosis, lung cancer or chest X-ray showing lung problems.
- •Known history of drug or alcohol abuse.
- •Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •Pregnant and lactating women.
- •Subjects with clinically significant history of co-morbid condition (like, diabetes, immunodeficiency, HIV, HPV) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
- •Patients suffering from any condition which in opinion of the Investigator may interfere with the outcome for the study.
- •Subject with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≥ 2.5 X Upper Limit of Normal (ULN), Serum creatinine of ≥ 1.5 mg/dL.
- •Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.
- •Known hypersensitivity to, or intolerance of, study products or their formulation excipients.
结局指标
主要结局
To demonstrate that Investigational product is more effective than placebo for the management persisting cough. An improvement of 2 score (Cough Clinical Score) is expected in 25% of subjects treated with investigational product.
时间窗: Screening Day 0 Day 5 and Day 10
次要结局
- improvement of day-time cough score from between active and placebo.(Change in LCQ in between groups)