A controlled clinical study to evaluate the effect of Arka ksheera based Chitraka kshara sutra over Apamarga kshara sutra in the management of Bhagandara (Fistula in ano).
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Arka ksheera based Chitraka Kshara sutra in terms of time taken by kshara sutra to cut through the tract with the application of unit cutting time formula.
研究概览
简要总结
Fistula-in-ano is a tract lined by granulation tissue which connects perianal skin superficially to anal canal; anorectum or rectum deeply. It usually occurs in a pre-existing anorectal abscess which burst spontaneously. Fistula-in-ano can be Cryptoglandular (90%) and Non cryptoglandular (10%).Fistula-in-ano according to park’s classification; Intersphincteric, Transphincteric, Suprasphincteric, Extrasphincteric. It is having clinical features like one or more external openings may be present with induration of the surrounding skin, seropurulent discharge and pain.1
In modern surgical treatment of Fistula in ano are Fistulotomy, Fistulectomy, Gluing of the Fistula tract, Anal Fistula Plug (AFP), Advancement flaps, LIFT technique, VAAFT procedure and Seton technique.2
Fistula in ano has been a troublesome disease to both patient and Physician to cure because of its recurrence rate. Fistula in Ano at modern parlance is a common anorectal condition prevalent in the populations worldwide. The overall incidence is about 9 cases per 100,000 population per year and those in their third, fourth and fifth decades of life are most commonly affected3.And is more common in young adult males than females with the ratio of 2:1 respectively.4
Bhagandara is a disease which causes tear or discontinuity in the region of Bhaga, Guda and Basti. According to Acharya Sushrutha, Bhagandara is a condition which is developed from bursting of painful and suppurated Pidika. He clearly differentiated the Bhagandara Pidika with other Pidika stating that if the Pidika is within two fingers area of Guda (anus), deep rooted, with pain and fever, it should be considered as Bhagandara Pidika.5Bhagandara (fistula-in-ano) is one among the most common anorectal disease.
It can be correlated with fistula-in-ano because of its similar clinical features. Five types of Bhagandara have been described as *Shataponaka (Vataja), Ushtragreeva (Pittaja), Parisravi (Kaphaja), Shambhukavarta (Tridoshaja), Unmargi (agantuja).*6Anorectal diseases like Bhagandara (fistula in ano) is said callous to be cured and Acharya Sushrutha had have considered Bhagandara one among the Ashta Mahagadas (eight grave disorders). Bhagandara is one of the oldest disease in Medical Science to be known.7
In modern world the medical science is so advanced in all aspects of treatments and surgical procedures but still the treatment for the fistula-in-ano is not yielding satisfactory results because of its high reccurrence rate. Kshara Sutra is one of the chief modalities in the treatment of Bhagandara in Ayurvedic science.8Exploration of the new plants for the preparation of Kshara as a better substitute to Apamarga Kshara is the need of the hour as it is available in the beginning of the year but Chitraka is available throughout the year. The idea came in mind to include Chitraka Kshara in place of Apamarga Kshara in making kshara sutra. To find out an effective alternative to Apamarga kshara sutra9 in view of easy availability throughout the year and attempt will be made to check the early healing of fistulous tract, an Arka ksheera based Chitraka kshara sutra10 over Apamarga kshara sutra were opted for their clinical evaluation**.**
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of either gender diagnosed with all Low Anal Fistulae except suprashincteric fistula.
- •Equal to or within 5cm Tract length of fistula.
排除标准
- •High Anal Fistulae Complicated Fistula multiple Fistula Extra-sphincteric Fistula.
- •Secondary Fistula in ano due to Ulcerative colitis Crohns disease Tuberculosis Carcinoma of rectum and Patients with systemic illness like Uncontrolled Diabetes mellitus Hypertension and if tract length is more than 5 cm.
- •HIV and HbsAg positive patients.
结局指标
主要结局
To evaluate the efficacy of Arka ksheera based Chitraka Kshara sutra in terms of time taken by kshara sutra to cut through the tract with the application of unit cutting time formula.
时间窗: 7 weeks
次要结局
- Recurrence of Bhagandara treated with Arka ksheera based Chitraka kshara sutra.(7 weeks)
研究者
Dr. Nikhil Sood
Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, Koppal
