CTRI/2019/04/018561
已完成
4 期
Evaluation of efficacy and safety of a proprietary digestive and carminative paediatric oral drop formulation in the management of indigestion and flatulence (colic) in infants and young children
East India Pharmaceutical Works Limited0 个研究点目标入组 200 人待定
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: K598- Other specified functional intestinal disorders
- 发起方
- East India Pharmaceutical Works Limited
- 入组人数
- 200
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •i.Infants \& young children of both sexes aged between 1 month and 2 years.
- •ii.Suffering from symptoms suggestive of indigestion, flatulence, chronic constipation, persistent loose stools or poor appetite in general (as perceived by the parent) with or without colicky abdominal pain.
- •iii.Parent or legally acceptable representative willing to provide written informed consent.
排除标准
- •i.Preterm infants (born before 37 completed weeks of gestation).
- •ii.Low\-birth weight infants (weighing less than 2500 gms at birth).
- •iii.Concomitant serious medical problems including failure to thrive.
- •iv.Known lactose intolerance or intolerance to infant feeding formulae (baby food).
- •v.Suffering from diarrhoea or loose stools which could be of infectious origin.
- •vi.Suffering from any other symptoms suggestive of an ongoing infection.
- •vii.Child receiving non\-permitted concomitant medication.
- •viii.Any other condition which in the opinion of the investigator is not conducive towards inclusion of the subject in the study.
结局指标
主要结局
未指定
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