A Pilot Clinical Trial to explore the efficacy of Siddha treatment in Powthiram (Anal fistula) using Karanool (Seton) coated with Sesame Salt, Papain and Turmeric – A Chemical ablation method.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1. The temporal difference in PDAI scoring in perianal fistula from baseline to healed status will be described.
研究概览
简要总结
Anal Fistula is one among the most commonly occurring anorectal diseases with ICD-11- DB50.1, here the chronic granulating track runs from anal canal or rectum to perineum or perianal skin. Anal fistula is an epithelialized connection between the anal canal and perianal area externally. It is characterized by inflammatory and granulation tissues with tenacious infection. Till date, surgery is the mainstay of treatment worldwide for anal fistula, but with sizeable percentage of recurrences. There is no simple technique that can completely eliminate the infection and heal various kinds of anal fistula. Hence, an alternate method of management is needed to institute a complete cure by permanently eliminating the infection. Phyto-salt of Sesame (Elluppu), papain powder of papaya latex and turmeric will be used for preparing Karanool (medicated thread) that would be used as seton to drain and burn the infection. The patients will be followed till their healed status and post-treatment for 5 years to declare the possible cured status.
研究设计
- 研究类型
- Interventional
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 with pain and discharge continuously or intermittently Fistula in ano patients having single tract of length less than 8 cm without abscess (St. James University Hospital MRI Classification of Anal fistula – grade I).
排除标准
- •Crohn’s disease Ulcerative colitis Urogenital tuberculosis Uncontrolled metabolic disorders Intra-abdominal abscess Intestinal and pelvic malignancies Infection of pelvic bones Venereal diseases, STD/HIV.
结局指标
主要结局
1. The temporal difference in PDAI scoring in perianal fistula from baseline to healed status will be described.
时间窗: At baseline, weekly assessments, at endpoint
As its a pilot clinical trial, Sample size has been chosen as per ICMR guidelines.
时间窗: At baseline, weekly assessments, at endpoint
次要结局
- Efficacy of Sesame Karanool therapy in perianal fistula will be documented.(Improvement in the Quality of Life of the patient with anal fistula from baseline to endpoint will be measured using QOLAF-Q.)
研究者
Prof Dr G J Christian
National Institute of Siddha