A Randomized Controlled Clinical Trial on The Effect Of “Ksharsutra treatment†(Ayurvedic Medical Seton) Vs Conventional Surgical Treatment in Clinical Outcomes of Patients with Fistula-In-Ano
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Guggulu-based Ksharsutra treatment vs. conventional surgical treatment in primary healing of fistula-in-ano
研究概览
简要总结
1.Fistula-in-ano is oneof the most common inflammatory anorectal diseases affecting the perianalregion including the sphincter muscles, ischioanal fossae, and the perianal skin
2. Ksharsutra is awidely accepted parasurgical treatment
3.Thisprocedure has multitude of advantages over conventional surgical therapy; likeit is an ambulatory procedure throughout the course of intervention and doesn’trequire extensive hospital stays which is cumbersome to the patient and thetreatment cost per patient is comparatively less . Ksharsutra has a betterpost procedural scarring, quality of life and less recurrence compared to theconventional surgery.It is observed that while performing Ksharsutra techniquessphincteric tone can be preserved leading to minimal incontinence in patients.Besides, Ksharsutra offers a relatively less invasive method for tacklingfistula-in-ano as compared to surgery, which can have recurrence rates of20%-40%, while exposing the patient to risk of anesthetic complications as wellas prolonged hospital stay.
4.The Indian Council ofMedical Research has validated [15] this therapy by conducting multicentricresearch trial and concluded that Ksharsutra is better than conventionalsurgery in fistula‑in‑ano.
5.over the yearsadvancement in the field of Ayurvedic pharmaceutics has led to value addition& pharmaceutical modification in Ksharsutra. There has been a number ofresearches on the variants of classical Ksharsutra like nimba, aragwadha,udumbara Ksharsutra.One such modifiedform of classical Ksharsutra known as Guggulu Ksharsutra is also researched
- This research study is proposed tocompare the effect of Guggulu based Ksharasutra in Fistula-in-ano vs. conventional surgical treatment modalities to understand its effect in healing,recurrence and other morbidities associated with fistula-in-ano. This studyalso proposes to evaluate and put forward the findings to clinical practice.The treatment modalities will also be compared for the purpose of complete healingof fistulous tract while preserving sphincter complex and improving quality oflife in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants having low anal fistula (subcutaneous, submucosal, inter sphincteric fistula & trans sphincteric with less than 30% involvement of external sphincter) with single tract or multiple small tracts within 2-3 cm of each other and within 5 cm of anal verge diagnosed during clinical examination.
排除标准
- •1.Age < 20 years or >70 years 2.Severely immunocompromised or compromised cardio pulmonary status 3.Participants with uncontrolled comorbidities such as diabetes mellitus and hypertension 4.HIV/hepatitis B/VDRL positive 5.Colorectal carcinoma 6.Ulcerative colitis & Crohn’s patients 7.On anti-tubercular therapy 8.Fistulas other than ano-rectal like recto vaginal fistula etc.
- •9.Anterior fistula-in-ano in women & pregnant women 10.Osteomyelitis.
结局指标
主要结局
To evaluate the efficacy of Guggulu-based Ksharsutra treatment vs. conventional surgical treatment in primary healing of fistula-in-ano
时间窗: 3 months
次要结局
- To compare the recurrence rates of anal fistula between the Guggulu-based Ksharsutra treatment & conventional surgical treatment during follow-up(3 months)
- To evaluate the impact of both interventions on perianal symptoms including itching, discharge, burning sensation, pain, & anal incontinence at follow up(3 months)
- To assess the unit cutting time & healing time associated with the Ksharsutra intervention(3 months)
- To compare the duration of hospital stay & number of hospital visits required in both treatment groups.(3 months)
- To evaluate the cost-effectiveness of Guggulu-based Ksharsutra treatment compared to surgical management.(3 months)
- To assess the number of workdays lost due to the disease & its treatment in both groups(3 months)
- To evaluate & compare the quality of life post-treatment using standardized tools such as the Gastrointestinal Quality of Life Index (GIQLI) & Fecal Incontinence Quality of Life Scale (FIQOL)(3 months)