A Clinical study to evaluate the effect of Panchavalkala kera thaila in Acute Fissure in ano
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano
研究概览
简要总结
A CLINICAL STUDY TO EVALUATE THE EFFECT OF PANCHAVALKALA KERATHAILA IN ACUTE FISSURE IN ANO
Fissure in Ano is an elongated ulcer in long axis of lower anal canal. In acute fissure, there will be spasm of anal sphincter muscle, pain on defecation, and passage of bright streaks of blood after passing stool. The signs and symptoms of fissure in ano can be compared with parikartika as per Ayurveda. Management of this condition includes vatanulomana, shoolahara and vranaropana measures. The drug of choice in present study is Panchavalkala which is mentioned in Bhavaprakasa Nighantu. The aim of the study is to assess effect of anal instillation with panchavalkala kerathailam in Acute fissure in Ano. This will be a single arm pre test and post test clinical trial. 31 participants diagnosed with acute fissure in ano within age group of 18 to 50 years satisfying inclusion and exclusion criteria will be selected from Pankaja Kasthuri Ayurveda Medical college hospital. The selected participants will be managed by anal instillation with Panchavalkala kerathaila for 7days. Assessment of ulcer in ano, pain and bleeding from fissure is done on before treatment, 8th day, and follow up on 15th and 22nd day. The data collected will be analyzed statistically using approppriate statistical techniques
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects within age group of 18 to 50 years Subjects recruited irrespective of gender fulfilling diagnostic criteria of acute Fissure in ano mentioned above Subjects willing to sign consent form.
排除标准
- •Fissure in ano secondary to diseases like Crohns disease Tuberculosis Syphilis Ulcerative colitis malignancy etc Subjects with known case of carcinoma of rectum Subjects with uncontrolled Diabetes Mellitus and Hypertension Pregnant ladies.
结局指标
主要结局
To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano
时间窗: To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano | Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day.
To evaluate the effect of anal instillation with Panchavalkala Kerataila in acute Fissure-in-ano
时间窗: To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano | Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day.
Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day.
时间窗: To assess the effect of anal instillation with Panchavalkala Kerataila in acute Fissure in ano | Assessment of ulcer in ano, pain, bleeding from fissure at baseline, 8th day and follow up on 15th and 22nd day.
次要结局
未报告次要终点