An open label single arm clinical study on Revalidation of Sushrutokta Chandrachakra incision followed by Kshara karma in Parisravi Bhagandara
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Identifying the fistula tract, probing, chandrachakra incision followed by kshara karma procedure. Pain, pus discharge, itching,size of wound, induration, granulation tissue parameters will be assessed.
研究概览
简要总结
Bhagandara is a chronic illness which is correlated to fistula in ano. Fistula in ano is an abnormal communication between epithelial lined surface having non healing unhealthy granulation tissue. In Ayurveda Acharyas have described Chedana karma for management of Bhagandara with different types of incision.
The main aim and objective of the study is to revalidate Acharya Sushrutas Chandrachakra incision followed by kshara karma in Parisravi Bhagandara. Sample source - subjects fulfilling diagnostic criteria. Diagnosis by confirming following signs and symptoms of Parisravi Bhagandara after thorough digital, rectal, proctoscopic examination of subjects, like presence of external opening near anal canal, pain, itching, discharge.
Intervention - Pre operative procedure like physical fitness will be taken, inform and written consent will be taken, nil by mouth for 6 hours prior to surgery, part preparation followed by proctoglycerin enema will be given, injection TT intramuscular and injection lignocaine test dose subcutaneous will be given.
Operative procedure - under all aseptic precautions spinal anaesthesia will be given, part will be painted with povidone iodine solution and draped in the lithotomy position. External opening of fistulous tract will be identified and probed. Chandrachakra incision will be taken over external opening, excision of tract followed by kshara karma will be done. Complete hemostasis will be achieved. Anal packing will be done.
Post operative procedure - Subject will be shifted to post operative ward, catheterization will be done. Foot end elevation, restricted head movements will be advised. The vitals will be monitored every 2nd hourly. Liquid diet will be started orally after appreciable bowel sounds heard .
The following subjective and objective parameters will be assessed before and after surgery. Subjective parameters are pain, itching, discharge. Objective parameters are size of wound, induration, granulation tissue. These parameters will be assessed on 1st, 7th, 14th, 21st, 28th. On completion of treatment the subjects will be asked to visit the opd after 15 days. Paired t test, wilcoxon signed rank test will be made use of for statistical analysis.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects fulfilling diagnostic criteria of Parisravi Bhagandara Diagnostic criteria.
- •Presence of external opening near anal canal, pain, itching, discharge.
排除标准
- •Pregnant and lactating women
- •Rectovaginal fistula, Rectovesical fistula, Rectoscrotal fistula
- •CA of rectum, HIV, Hepatitis B, uncontrolled DM
- •Fistula secondary to Tb, crohns disease, ulcerative colitis.
结局指标
主要结局
Identifying the fistula tract, probing, chandrachakra incision followed by kshara karma procedure. Pain, pus discharge, itching,size of wound, induration, granulation tissue parameters will be assessed.
时间窗: 2 to 3 days
次要结局
- Healed fistulous tract(Healed fistulous tract)
- Subjective parameters like pain, pus discharge, itching will be assessed. Objective parameters like size of wound, induration, granulation tissue will be assessed.(4 weeks)