跳至主要内容
临床试验/CTRI/2023/09/057816
CTRI/2023/09/057816尚未招募2/3 期

Evaluation of fistulous tract by histo pathological study on the efficacy of Ksharasutra in Fistula in ano

Dr Shreeram P A1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Complete healing of the peri anal fistula with healthy granulation tissues in the histo pathological specimens

研究概览

简要总结

A track with epithelial lining that connects the anal canal to the perianal skin is known as a fistula-in ano. Anorectal abscesses are the most frequent cause of anal fistulas, while they can occur for a varietyof reasons. Men experience the prevalence at a rate of 12.3 cases per 100,000 and women at 5.6instances per 100,000 respectively. The majority of diagnoses happen between the ages of 20 and 40,with a 38-year-old average. Obesity, diabetes, smoking, hyperlipidemia, and a sedentary lifestyle arerisk factors for fistula formation. Sushruta discussed the genesis, clinical appearance, and therapy ofBhagandara. The description of several varieties of Bhagandara (fistula-in-ano) is comparable to theaetiopathogenesis of Fistula-in-ano as it is understood by contemporary medical research. It is a verycomplex illness brought on by a number of causes including inflammatory bowel disorders likeCrohn’s disease and ulcerative colitis, as well as pyogenic, tubercular, lymphogranuloma inguinale,and others. This is a condition where there is a need of invasive surgical interventions likeFistulectomy, LIFT, Fistulotomy, VAAFT etc. which are costly, risk-bearing and needhospitalization. The chances of recurrence after these surgeries are also high and development ofcomplications like fecal incontinence are also seen after these invasive procedures. Kshara Sutra is apara surgical intervention mentioned in Ayurveda classics to treat Fistula in Ano which is a minimallyinvasive and cost-effective treatment with a very low chance of recurrence and carries minimal amountof risks. The efficacy of Kshara Sutra in Fistula In Ano has been studied and proved from time totime, but no study has been conducted to understand the action of Kshara sutra on the tract on a cellularlevel. Hence in order to study and understand the action of Kshara sutra on a cellular level thisHistopathological study is being conducted. Tissue from the tract of the fistula-in-ano can bestudied histo-pathologically to determine the efficacy of Kshara Sutra treatment. In this study, a biopsy will be taken from the fistulous tract at regular intervals and histopathological changeswill be observed to determine the action of Kshara Sutra and its mechanism in the healingprocess

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients having Fistula in Ano.
  • Patients fulfilling the diagnostic criteria.
  • Patients who have signed the written informed consent.

排除标准

  • Patients suffering from:- 1) All infectious diseases 2) All Malignancies 3) Rectal polyps 4) Rectal prolapse 5) Uncontrolled diabetes mellitus and Hypertension Anemia 6) Congenital anomalies of the anus and rectum 7) History of acute bleeding 8) K/C/O Ulcerative colitis and Crohn’s disease.
  • Pregnant And Lactating Women.

结局指标

主要结局

Complete healing of the peri anal fistula with healthy granulation tissues in the histo pathological specimens

时间窗: 6 weeks

次要结局

  • Complete healing of the fistula tract with healthy granulation tissues in the histo pathological specimens(3 weeks)

研究者

发起方
Dr Shreeram P A
申办方类型
Other [self]

研究点 (1)

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