CTRI/2023/07/055763尚未招募2/3 期
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF AJAMODA ARKA IN UDARSHOOL IN KSHEERAPAVASTHA.
Dr Surabhi Arun Yadgire1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月8日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare efficacy of Shunthi Arka with Avartani Arka 0.16ml/kg/day Vyanodane in Udarshool in Ksheerapavastha for 5 days.
研究概览
简要总结
This study is randomised controlled clinical trail study to evaluate the efficacy of Ajamoda Arka in Udarshool in Ksheerapavstha. Study will be carried in Kaumarbhritya OPD of Yashwant ayurvedic College and Hospital kodoli . The observation would be drawn on the basis of signs after treatment given .
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 6.00 Month(s)（—）
入选标准
- •Children of Ksheerapavastha i.e. 0-1 years irrespective of Gender.
- •Patients having at least any two of the following symptoms of udarshool, like excessive cry, refusal to feed, irritability, abdominal distension or tenderness, etc.
- •As mentioned in Ayurveda classics (Kaashyap samhita) and according to modern textbooks.
- •Patients having history of crying for more than 3 hrs/day, for more than 3 days in week, for at least 1 week.
- •OR patients having history of at least any two of the following symptoms of udarshool, like excessive cry, refusal to feed, irritability, abdominal distension or tenderness, etc.
排除标准
- •Udarshool associated with fever, vomiting, diarrhoea, constipation, acute infectious diseases like Gastro intestinal tract infections, urinary tract infections etc.
- •Known case of congenital anomalies.
- •Patient having food allergies like lactose intolerance, IEM etc.
- •Failure to thrive.
结局指标
主要结局
To compare efficacy of Shunthi Arka with Avartani Arka 0.16ml/kg/day Vyanodane in Udarshool in Ksheerapavastha for 5 days.
时间窗: To compare efficacy of Shunthi Arka with Avartani Arka 0.16ml/kg/day Vyanodane in Udarshool in Ksheerapavastha for 5 days.
次要结局
- To study the adverse effect of Shunthi Arka if any.(5 days)
研究者
研究点 (1)
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