“A open clinical trial to evaluate the efficacy of Kuka cough lozenges variants in the patient suffering with Kasa (Acute cough and throat irritation).â€
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in day/night time cough scales and throat irritation will be evaluated over a period of 3 days from baseline on verbal category descriptive (VCD) scale scores
研究概览
简要总结
The present research project is for a randomized clinical trial to evaluate the safety and efficacy of Kuka cough lozenges variants in the subjects suffering with acute cough and throat irritation proposed to be carried out at NIA, Jaipur. Kuka cough lozenges (KCL) has four variants which are KCL Tulsi orange, KCL Tulsi ginger, KCL Tulsi lemon and KCL Tulsi mint. 120 Subjects will be randomly recruited from the OPD NIA, Jaipur, who will fulfill the inclusion criteria and will willing and able to provide signed informed consent form (ICF) prior to the study initiation and will be divided into 4 Groups.
For each variant one group will be created and, 30 patients will be recruited in each group. Effect of the lozenges will assessed after 2 hours of administration on Day 1 and then on Day 3. Day 0 will be considered as baseline and effect of the therapy will be analyzed on the basis of it. Follow up of the subjects will be for 5 days for checking the recurrence of disease.
Plan of analysis (analysis of data): For statistical analysis of data ANOVA, wilcoxan test will be used to analyzed and compare the subjective measures. P value <0.05 will be considered as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females with a history of acute cough due to any cause except those listed in exclusion criteria.
- •Throat irritation for <1 week duration, who will be able to comply with the study requirements
- •Patients having a cough score of 0, 1 or 2 during day time (as per Day Time Cough Scale described under end points)
- •Patients willing and able to provide signed ICF prior to study.
排除标准
- •Participants with a history of acute lower respiratory tract infections such as pneumonia, bronchitis whooping cough, chronic obstructive pulmonary disease/asthma, tuberculosis, systemic bacterial infections for which specific drug therapy will be required;
- •Any underlying lung pathology such as lung abscess or cystic fibrosis
- •Individuals with a history of myocardial infarction within 4 weeks prior to enrollment;
- •Individuals with a history of Parkinson’s disease and who were on monoamine oxidase inhibitors.
- •Individuals with any psychiatric illness which may impair the ability to provide written ICF.
- •Individuals participating in any other clinical trial.
- •Pregnant or lactating females.
- •Those who are under study treatment or any other condition due to which individuals are deemed unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria
- •Alcohol, smoke, and drug abusers will be excluded.
结局指标
主要结局
Changes in day/night time cough scales and throat irritation will be evaluated over a period of 3 days from baseline on verbal category descriptive (VCD) scale scores
时间窗: 8 days
次要结局
- Time to relief from cough and throat irritation for all the first morning doses, duration of relief from symptoms for all first morning doses, drowsiness, and Physician’s Global Assessment of efficacy evaluated at visit 4 in both the treatment groups on VCD scales(8 Days)