A single arm clinical study to evaluate the efficacy of Saindhavadi churna in the management of Udarshool(abdominal pain) in children between 6 months and 6 years.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To decrease episodes of Udarshool(abdominal pain)
研究概览
简要总结
This is a single arm clinical study in which the medicine Saindhavadi churna will be provided to 35 patients showing signs and symptoms of Udarshool(abdominal pain). The age group taken for the trial will be between 6 months and 6 year. Saindhavadi churna with go grihta(cow ghee) will be given for 5 days thrice a day. Dose will be calculated according to the dose of churna given in Sharangdhar Samhita. Follow up will be done on the 3rd and 5th day and the total duration of case study will be 5 days. The final conclusion will be drawn based on statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with age group of 6 months to 6years of either gender will be selected.
- •2.History of frequent abdominal pain.
- •3.Patients having a history of symptoms of Udarshool (Abdominal pain) mentioned in Kashayap Samhita and modern texts like excessive crying, stiffness of the abdomen, perspiration of the face, coldness.
- •4.The patients who are ready for participation in clinical trial by giving informed written consent.
排除标准
- •1.Patients with any known case of congenital anomalies.
- •2.Udarshool (Abdominal pain) is associated with Jwar (Fever), Chardi (Vomiting), Atisar(Diarrhea), Pravahika(Dysentery).
- •3.Patients who require surgical management.
- •4.Severe persistent and acute abdominal pain.
结局指标
主要结局
To decrease episodes of Udarshool(abdominal pain)
时间窗: 5 days study with follow up on 3rd and 5th day (0,3,5 days)
次要结局
- To study the adverse effect, if any of Saindhavadi Churna.(5 Days study with follow up on 3rd and 5th day(0,3,5 days))
研究者
Dr Himanshi Deora
Dr.D.Y.Patil College of Ayurved and Research Centre,Pimpri pune