Single arm clinical study to assess the efficacy of Jeerak Ark in Udarshool with special reference to Infantile Colic.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of Jeerak Ark in Udarshool with special reference to Infantile Colic
研究概览
简要总结
Aim-To study the efficacy of Jeerak Ark in the management of Udarshool with special reference to Infantile Colic
Primary objective-To study the efficacy of Jeerak Ark in the management of Udarshool in infants
Secondry objective-To study literature regarding Udarshool in ayurveda literature
To study literature regarding Infantile Colic (Abdominal pain) from modern perspective
Study design-Single arm purposive clinical trial
Study setting-Patient will be selected in OPD and IPD of Kaumarbhritya department in our hospital
Duration of study-18 months
Duration of treatment-6 days
Follow up-1st hr,2nd day,4th day,6th day
Diagnostic phase-Patient will be diagnosed on lakshanas of Udarshool described in ayurvedic classics modern symptoms
Informed written consent will be taken prior to clinical study
Case will be recorded on specially designed proforma
Assessment phase-Subjective Parameter-
1 Rodan(cry)
2 Stanam vyadasyaste (Aversion to feed)
3 Skin on touch (cold and perspiration)
4 Duration of spasm
Objective parameter-
1 Frequency of sleep disturbances
2 Vomiting in 24 hr period
Discussion will be made scientifically in details after results and conclusion will be drawn
The efficacy of drug will be concluded on the basis of observation and statistical analysis
On the basis of observation,result and discussion summary will be drawn and whole disc5 work will be summarised
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
- 0.00 Day(s) 至 6.00 Month(s)（—）
- 性别
- All
入选标准
- •1 Patient of age group from neonate to 6 month 2 Patient will be selected irrespective of age sex religion socio economic condition and geographical distribution 3 Full term healthy neonate suffering from definitive symptoms of infantile colic 4 Patient regularly passes urine and stool normally 5 Patient having bloating and distended abdomen followed by continuous cry.
排除标准
- •1 Patient more than 6 month 2 Patient associated with symptoms like diarrhea fever and any other pathology 3 Patient who is having congenital anomoly or metabolic problem 4 Patient with unstable vitals.
结局指标
主要结局
To evaluate efficacy of Jeerak Ark in Udarshool with special reference to Infantile Colic
时间窗: 6 days
次要结局
- 1 To study the clinical textual review of Udarshool in neonate according to ayurveda and Infantile Colic according to modern text(2 To study efficacy of Jeerak Ark in management of Infantile Colic)
研究者
Dr Bushra Imran Shaikh
LRP Ayurvedic Medical College and Hospital,PG Institute and Research Centre Urun Islampur.