A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF ARKAKSHEERA BASED ARKAKSHARASUTRA AND APAMARGA KSHARA SUTRA IN BHAGANDARA WITH SPECIAL REFERENCE TO FISTULA-IN-ANO
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Unit Cutting Time
研究概览
简要总结
Bhagandara is one among common ailments pertaining to guda. In Sushruta Samhita
‘Bhagandara’ is told as Mahagada due to its grave nature 1 .
In contemporary medical science, description of Fistula-in-ano, which can be correlated with
Bhagandara - is an unhealthy track with an external opening in the skin of perianal region and an internal
opening in the modified skin or mucosa of anal canal or rectum. Fistula-in-ano is considered second to
Hemorrhoids among all ano-rectal abnormalities. The disease is prevalent all over the world and its
occurrence in London Hospital (Study by Marks & Richie, 1977) was reported to be 10% of all in patients
and 4% of all new out patients. Study in India (Raghavaiah, 1976) reported anal fistula to constitute 1.6% of
all surgical admissions. Eminent surgeons have reported 67.9% - 85% recurrence.
These statistical data reveal the fact that treatment of anal fistula is still far from the success and
needs a vital reconsideration.
Acharya Sushruta has explained surgical procedure to combat the disease. But there is always a risk
of recurrence. Ksharasutra is first explained by Acharya Chakrapanidatta 2 and is one such reliable
treatment. Acharya Sushruta mentioned the application of ksharasutra in Nadi vrana 3 .
Though Apamarga Kshara sutra is considered standard, problems are faced during collection
(seasonal) and preservation of Snuhiksheera, and also in course of Kshara sutra treatment like local skin
irritations and pain. To overcome these disadvantages ARKAKSHEERA BASED ARKA
KSHARASUTRA is being tried in the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Irrespective of religion, occupation and duration of symptoms Patients with clinical features of Fistula-in-ano namely pain, sero-purulent discharge from the tract and pruritis ani, confirmed by clinical examinations and investigations patient with patent fistulous tract confirmed by probing.
排除标准
- •Diagnosed cases of Fistula in ano secondary to Tuberculosis, Osteomyelitis and malignancies Associated with other diagnosed anorectal disorders Pregnancy and lactation mother Patients suffering with other diagnosed systemic disorders Recurrent fistula in ano after previous surgery.
结局指标
主要结局
Unit Cutting Time
时间窗: Outcome is assessed on the 7th day after Probing and Primary threading and on every week while changing kshara sutra till the Fistulus tract is completely cut
Pus Discharge
时间窗: Outcome is assessed on the 7th day after Probing and Primary threading and on every week while changing kshara sutra till the Fistulus tract is completely cut
次要结局
- Pain(Outcome is assessed on 7th day of kshara sutra insertion)