CTRI/2024/02/063048已完成Unknown
A Prescription Event Monitoring (PEM) Study to Evaluate the Effects of Adjuvant Therapy with ZincorespTM Syrup in Children Aged 2- 12 Years Having Recurrent Respiratory Disorders and Infections.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Improvement in symptoms of respiratory disorders and/or infections
研究概览
简要总结
All eligible subjects who meet the inclusion and exclusion criteria will be part of the study. A detailed history will be obtained from the parents of children included in the study. After baseline assessment, a children will be followed-up during the study period (week 1 ± 3 days, and week 2 ± 3 days, week 3 ± 3 days week 4 ± 3 days, week 8 ± 3 days, week 12 ± 3 days]
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 2-12 years of age of any gender.
- •Children having recurrent episodes of any of the following:.
- •Fever associated with respiratory tract infections (RTI).
- •URTI (rhinitis, pharyngitis, laryngitis, otitis media, influenza).
- •LRTI (pneumonia, bronchitis, and bronchiolitis).
- •Bronchial asthma.
- •Combined allergic rhinitis and asthma syndrome (CARAS).
- •Pulmonary tuberculosis 3.Parents are willing to give consent for the child’s participation in study.
排除标准
- •Any evidence of malignancy.
- •History and clinical findings suggestive of metabolic diseases
- •History and clinical findings suggest chronic respiratory tract diseases including interstitial lung disease (ILD) and cystic fibrosis.
- •History of respiratory tract surgery.
- •Known diagnosis of congenital cardiac defects.
结局指标
主要结局
Improvement in symptoms of respiratory disorders and/or infections
时间窗: Baseline to Week 12
次要结局
- Total number of children with at least one episode of upper respiratory tract infections((rhinitis, pharyngitis, laryngitis, otitis media, and influenza))
- Total number of children with at least one episode of lower respiratory tract infections((pneumonia, bronchitis, and bronchiolitis))
- Total number of children not having any episode of respiratory tract infections (URTI or LRTI) or exacerbations of existing conditions(Baseline to Week 12)
- Total number of children with Bronchial asthma, Combined allergic rhinitis and asthma.(syndrome (CARAS).)
- Total number of children experiencing at least one episode of fever during the study period.(Baseline to Week 12)
- Total number of children requiring antimicrobial agents (antibiotics and antiviral drugs) during the study period.
- Total number of children requiring hospital admission, but not requiring supplemental(oxygen during the study period.)
- Total number of children requiring hospital admission, requiring supplemental oxygen(during the study period.)
- Number of days of hospitalization required during the study period.(Baseline to Week 12)
- Total number of days of work lost by the parents due to the child’s illness during the study period.(Baseline to Week 12)
- Total number of episodes of infections lasting more than 7 days during the study period.(Baseline to Week 12)
- Time required to recover completely from infection during the study period.(Baseline to Week 12)
- Investigator global assessment for efficacy(Week 12)
- Investigator global assessment for safety and tolerability(Week 12)
研究者
Dr Vaishali Thakare
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai
研究点 (1)
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