A clinical study to evaluate the efficacy of classical ksharsutra and ksharsutra coated with shodhan dravya in the management of bhagandar w.s.r. to fistula in ano: an open-label randomized trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
研究概览
简要总结
Bhagandara, known as fistula-in-ano in modern medicine, is a chronic anal condition marked by a pus-discharging tract between the anal canal and perianal skin.
Ayurveda classifies it among the Ashta Mahagada, highlighting its complex and recurrent nature.
Modern treatments for fistula like fistulectomy and fistulotomy have limitations, Ayurveda offers Ksharsutra therapy—a para-surgical method using a medicated thread prepared with herbal alkaline drugs. This thread, traditionally coated with Snuhi latex, Apamarga Kshara, and Haridra, is effective in excising, cleaning, and healing the tract. However, it may cause discomfort and delayed healing in some patients.
Recent innovations suggest modifying the Ksharsutra with Vranashodhana Dravyas to enhance healing, reduce pain, and improve outcomes.
A comparative clinical study is proposed to evaluate the benefits of this modified approach in managing Bhagandara more effectively.
Ksharsutra therapy, an Ayurvedic para-surgical method, offers benefits like minimal recurrence, sphincter preservation, and simultaneous cutting and healing.
However, the classical Apamarga Ksharsutra may cause local irritation, prolonged healing, and discomfort in some patients.
Enhancing the Ksharsutra with wound-cleansing (Vranashodhana) herbs may address these issues. A clinical study is essential to evaluate whether the modified Ksharsutra improves healing time, reduces discomfort, and lowers recurrence ultimately aiming to refine treatment protocols and enhance patient outcomes in Ayurvedic management of Bhagandara.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Low anal fistula in ano , upto length 5cm Diagnosed cases of bhagandar(fistula in ano) Patient willing to consent and follow protocol Willing to come for regular follow-up.
排除标准
- •Patients aged below 18 and above 60 years.
- •Tubercular ,crohn’s or malignant fistula.
- •Hiv and immunocompromised patient Patient who on long term steroid or unfit for surgery High anal fistula and horse-shoe fistula.
- •Complicated fistula in ano( fistula with piles and other anorectal diseases).
研究者
Dr Ajitkumar Barot
Shree Swaminarayan ayurvedic college kalol
