Histo pathological Study of Fistula Tract after Kshara Sutra

Phase 2/3

Not yet recruiting

Conditions: Anorectal fistula. Ayurveda Condition: BAGANDARAH,

Registration Number: CTRI/2023/09/057816

Lead Sponsor: Dr Shreeram P A

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1)Patients having Fistula in Ano.
2)Patients fulfilling the diagnostic criteria.
3)Patients who have signed the written informed consent.

Exclusion Criteria

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 Crohnâ€™s disease.
1. Pregnant And Lactating Women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete healing of the peri anal fistula with healthy granulation tissues in the histo pathological specimens	6 weeks

Secondary Outcome Measures

Name	Time	Method
Complete healing of the fistula tract with healthy granulation tissues in the histo pathological specimens	3 weeks

Trial Locations

Locations (1): Sri Jayendra Saraswathi Ayurveda College And Hospital
🇮🇳
Thiruvallur, TAMIL NADU, India
Sri Jayendra Saraswathi Ayurveda College And Hospital
🇮🇳Thiruvallur, TAMIL NADU, India
Dr Shreeram P A
Principal investigator
8281631404
shreerammarch@gmail.com