Single arm clinical study to evaluate the efficacy of shatavaryadi granules with madhu and sheeta kshira in management of garbhini parikartika fissure in ano in pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of shatavaryadi granules with madhu and sheeta kshira in management of garbhini parikartika (fissure in ano in pregnancy) which will be assessed by the symptoms bleeding during defecation, itching over anal region, severe constipation, burning at anal region
研究概览
简要总结
This is a single arm clinical study. The aim of this study is evaluate the efficacy of shatavaryadi granules with madhu and sheeta kshira in management of garbhini parikartika . Total 40 patients will be enrolled and 10gm shatavaryadi granules will be given with madhu and sheeta kshira twice a day after meal for 15 days. The age group taken for study is 21 to 40 years women. The final conclusion will be drawn on the the basis of 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
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Garbhini with age group of 19 to 40 years will be selected.
- •Garbhini having atleast 3 symptoms of following: -severe constipation.
- •Pain during fecation -burning sensation at anal region -Bleeding at anal region 3.Both primigravida or multigravida In 2nd and 3rd trimister.
排除标准
- •Patients having any chronic or systemic illness.
- •Patient suffering from acquired or congenital immune deficiency.
- •Patients having intussusceptions.
- •Pt having any other associated diseases like pregnancy induced diabetes, pregnancy induced hypertension.
结局指标
主要结局
Effect of shatavaryadi granules with madhu and sheeta kshira in management of garbhini parikartika (fissure in ano in pregnancy) which will be assessed by the symptoms bleeding during defecation, itching over anal region, severe constipation, burning at anal region
时间窗: 14 days study with follow up on 7th day
次要结局
- To observe adverse of shatavaryadi granules with madhu and sheeta kshira(14days study with follow up on 7th and 14th day)
研究者
Drshubhangi Dhanraj Sonwane
Dr.D.Y.Patil ayurvedic medical College and research centre pimpri pune