A randomized, open label, interventional clinical study to assess the Efficacyand Safety of EMCOF cough syrup for the symptomatic treatment of acuteand Chronic Productive and non-productive cough .
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1)Change in the daytime cough symptom scores and cough rating scale at end of 5 days (120 hrs) of first examination as compared to the baseline
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 50 participants will be randomized in tos ingle group.Dosing will be done daily orally twice or thrice daily for 5-7 days. Subjects will be asked to visit clinical facility/ institution for their follow up at the end of day 2 , day 5 and day 7 and any other additional visits if needed.
Primary and Secondary Outcome
-
Change in daytime Cough symptom scores
-
Change in Night time Cough Symptom
-
Reduction of Pharyngeal pain
-
VAS Score
-
Proportion of patients having a confirmed Best Response or partial Response or Complete Response
-
To assess quality of Life using Leicestar Cough Questionnaire (LCQ-acute)
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
- 10.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to provide written informed consent to participate in the study
- •Male and Female patient in the age range of 10-65 years.
- •Patients with acute and Chronic,Productive or non-productive cough (Dry cough, Wet cough, Asthmatic cough, Allergic cough, Infective cough, Smokers cough, Sore throat, Hoarse cough, Ratting / Tickling cough) presenting in out patient setting.
- •Patients with a baseline daytime cough symptom score of at least 2.
排除标准
- •Female patient who is pregnant or lactating.
- •Patients or with clinically suspected lower respiratory tract infection (e.g. pneumonia tuberculosis)
- •Patients taking any other antitussives, sleeping pills, sedative medications, or herbal cough remedies;
- •Patients currently on any treatments that may influence cough.
- •Patient has history of hepatic or renal insufficiency
- •Any condition decided as unfit for study by Clinical investigator.
结局指标
主要结局
1)Change in the daytime cough symptom scores and cough rating scale at end of 5 days (120 hrs) of first examination as compared to the baseline
时间窗: Day 0, Day 2, Day 5 and Day 7
2. Change in Night time cough symptom scores and cough rating scale from the baseline to end of 5 days (120 hrs) of first examination as compared to the baseline
时间窗: Day 0, Day 2, Day 5 and Day 7
3. Reduction of pharyngeal(throat) pain(if present) before and at the end of 5 days- measured on Visual Analogue Scale (VAS) . [time frame: 5 days]
时间窗: Day 0, Day 2, Day 5 and Day 7
4. Use of rescue medication (Cough syrup). [time frame: 10 days]
时间窗: Day 0, Day 2, Day 5 and Day 7
5. Proportion of patients having a confirmed Best response or Partial Response or Complete response (10 days duration)
时间窗: Day 0, Day 2, Day 5 and Day 7
6. To assess the quality of life among the study participants using pre and post Study Leicester Cough Questionnaire (LCQ-acute)
时间窗: Day 0, Day 2, Day 5 and Day 7
Adverse events and serious adverse events during the study period
时间窗: Day 0, Day 2, Day 5 and Day 7
Brief clinical examination
时间窗: Day 0, Day 2, Day 5 and Day 7
次要结局
- 1)To demonstrate safety and tolerability of study product by Clinical AEs (If any)(2)Proportion of patients having a confirmed Best response or Partial Response Or Complete response (10 days duration))