Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- • To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks -
研究概览
简要总结
A cough is one of the most common medical complaints accounting for as many as 30 million clinical visits per year. It is the single most prevalent symptom on presentation to a physician's office. Up to 40% of these complaints result in a referral to a pulmonologist. Although, the cough is an essential defense mechanism, still, chronic cough may cause significant morbidity and substantially affect the quality of life and psychosocial wellbeing.
详细描述
Globally, the prevalence of acute cough is 9 to 64%, whereas chronic cough is >10% in most countries or regions, ranging from 7.2%-33%. In Pakistan, a few studies have examined chronic cough resulting from specific occupations, such as those involving brick kilns, textile work, or gem cutting. Additionally, 15.8% of subjects in a periurban area of Karachi City, Pakistan with cough lasting ≥ 2 weeks were found to have pulmonary TB. Overall, to estimate the prevalence and incidence of different coughs, there is no data available based on the local population, and the data assessing the quality of life of patients with different coughs is not available. Locally, few studies were conducted on cough syrups with a small sample size. However, no real data is available for the symptomatic management of cough about the patient's quality of life related to different coughs. The current study is designed to assess the response of different strengths of Syrup Hydryllin ( Syrup Hydryllin & Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan & Diphenhydramine) in the symptomatic management of cough in routine practice by physicians. The study's main objective is to assess the quality of life of the subjects suffering from the different types of cough.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a clinical history of cough.
- •Patients aged ≥12 and ≤70 years inclusive of either sex.
- •The patient will be screened for COVID-19
- •The patient will be prescribed the study drug following an approved package insert
- •Written informed consent before participation in study-specific procedures
排除标准
- •Known hypersensitivity to Hydryllin product, the metabolites, or formulation excipients.
- •Covid Patients with moderate and severe condition requires hospitalization or/and associated with the complications.
- •Patients who have a contra-indication (refer to the Syrup Hydryllin prescribing information).
- •Pregnant (assessed on LMP)
- •Breastfeeding women (assessed on interview).
研究组 & 干预措施
• Patient with a clinical history of cough
Syrup Hydryllin ( Syrup Hydryllin & Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan & Diphenhydramine) in the symptomatic management of cough in routine practice by physicians. Subjects will be observed for overall safety and effectiveness of study drug from visit 1 (baseline visit, screening, and start of treatment), to visit 2 (Week 1-2, end of treatment) in the routine practice.
干预措施: Syrup Hydryllin (Drug)
结局指标
主要结局
• To assess the effectiveness of Syrup Hydryllin from baseline to 2 weeks -
时间窗: 4 Months
The effectiveness assesses by Leicester Cough Questionnaire (QoL questionnaire), The LCQ scale from 1-7, 1 is all the time and 7 is none of the time. The total score is 19 whereas 8 for Physical, 7 for Psychological and 4 for Social.
次要结局
- • To assess the overall safety of different strengths of Syrup Hydryllin in the cases presenting with different types of cough.(4 Months)