CTRI/2023/03/050294招募中2/3 期
A Single Arm Clinical Study To Evaluate Efficacy Of Nishadi Taila In Treatment Of Nabhi Paka In Newborns
Dr.Shital Patil1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年3月15日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To reduce symptoms of Nabhi paka like redness, inflammation, swelling at umbilicus
研究概览
简要总结
This is single arm clinical study in which Medicinal oil Nishadi Taila will be provided to 35 patients showing classical signs and symptoms of Nabhi paka for relieving symptoms
The age group taken for study trail will be between 1 day to 1 month Nishadi Tail will be locally applied twice a day daily till 5 days Follow up will be daily one to five days. Total duration of case study will be 5 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 1.00 Month(s)（—）
- 性别
- All
入选标准
- •1 Newborn baby of age group from birth upto 1 month 2 Newborn baby having sign and symptoms of Nabhi paka like redness tenderness infammation and pus discharge from umbilicus 3 The patients whose parents are ready to participate in clinical trial by giving informed written consent.
排除标准
- •1 Baby born with thick meconium stained liquor 2 Baby with meconium aspiration syndrome 3 Baby having other major illnesses like cardiac neurological diseases.
结局指标
主要结局
To reduce symptoms of Nabhi paka like redness, inflammation, swelling at umbilicus
时间窗: Daily one to five days
次要结局
- To access healing of umbilical wound.(Daily one to five days)
研究者
研究点 (1)
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