CTRI/2020/04/024916尚未招募3 期
An Open Label, Single Arm, Non Comparative Study ofPolyherbal Pediatric Oral Drops (Zeal® Kid Drops) in Symptomatic Managementof Upper Respiratory Tract Infection (Common Cold & Cough)in infants and children
Vasu Research Centre A Division of Vasu Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Willing to provide written informed consent for participation in the study and adhere to the protocol requirements by parent.
- •Children of either sex having age group 3 months - 6 years (both inclusive).
- •Children presenting with symptoms of acute common cold prevailing for less than 48 hours.
- •Parentâ??reported nasal congestion severity score equating to stuffy or very stuffy (score 3 or 4 on a 5â??point categorical scale 0 [not stuffy at all] 1 [a tiny bit stuffy] 2 [a little stuffy] 3 [stuffy] 4 [very stuffy])Parents reporting of children having at least 2 of the following cold symptoms running nose, sneezing, sore throat, headache, body ache, Pyrexia and/or cough
排除标准
- •Hypersensitivity to any of the components of formulation or the
- •excipients of the formulation.
- •Signs or symptoms of a more treatable disease (e.g. asthma,
- •pneumonia, laryngotracheobronchitis, sinusitis, allergic rhinitis).
- •Children who have taken or should be taking or are taking antibiotics,
- •antivirals, steroids, nasal decongestants, antihistamines, or other
- •medications that are expected to alleviate cold symptoms, or those
- •who have taken food that is expected to relieve cold symptoms within
- •one week of the start of the study Children with other than acute
- •cough ( >2 weeks).
- •History of reactive airways disease, asthma, or chronic lung disease.
- •Any condition that in opinion of the Investigator, does not justify the
- •subjectsâ?? participation in the study.
研究者
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