A clinical study to evaluate the effect of Prapoundrikadi Ghrita in Parikartika (Fissure-in-ano)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment based on subjective parameters-
研究概览
简要总结
This is open label clinical study to evaluate the effect of Prapoundrikadi Ghrita in Parkartika. Patients will be selected randomly irrespective of gender race religion occupation. Total 30 patients will be registered for this study from OPD and IPD of Shalya Tantra department of Quadra Institute of Ayurveda Roorkee. The patients between age group 18 to 60 years. The assessment of the trial will be done on subjective and objective parameters. Deatailed profarma will be prepared on the basis of Ayurvedic and allied sciences. Observation of patients will be done before during and after completion of trial. Data depending upon above subjective and objective paramerters and other variables will be collected and analyzed statistically.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients age ranging from 18 to 60 years.
- •Patients clinically diagnosed by PR examination as having Parikartika.
- •Controlled case of Hypertention and Diabetes mellitus.
排除标准
- •HIV, HCV, HBsAg positive patients.
- •Patients having Parikartika secondary to Ulcerative colitis, Syphilis, Tuberculosis, Crohns disease.
- •Patients having anal or peri anal Cancer.
- •Fissure-in-ano associated with Piles, Fistula-in-ano.
- •Uncontrolled Diabetes mellitus and uncontrolled Hypertention.
- •Other systemic serious illness.
结局指标
主要结局
Assessment based on subjective parameters-
时间窗: First follow up- on 7th day | Second follow up- 7 days after first follow up | Third follow up- 14 days after second follow up
1.Bleeding
时间窗: First follow up- on 7th day | Second follow up- 7 days after first follow up | Third follow up- 14 days after second follow up
2.Pain
时间窗: First follow up- on 7th day | Second follow up- 7 days after first follow up | Third follow up- 14 days after second follow up
3.Constipation
时间窗: First follow up- on 7th day | Second follow up- 7 days after first follow up | Third follow up- 14 days after second follow up
次要结局
- Assessment based on objective parameters-(1.Size of split)
研究者
Amitabh Singh
Quadra Institute of Ayurveda and Hospital