A Pilot Clinical trial to determine the Efficacy of Siddha treatment with Panchapadana Chenduram and Meni thylam in the Management of Powthiram(Fistula in ano)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1. Number of patients achieved a Zero score of Peri Anal Disease Activity
研究概览
简要总结
Fistula in ano is a common surgical anorectal anomaly; it is notorious due to its chronicity,recurrences, and frequent exacerbations. A study conducted among the Indian rural population
estimated the incidence of low anal fistula around 8.6 per 1 lakh population with male to female ratio as 11.2:1.The disease ischaracterized by one or more external openings in the perianal region with an apparent internal opening anywhere in the anorectal mucosa. Pus discharge associated with mild to severe pain will be thepresenting feature.The goals in the treatment of an anal fistula are to eliminate the primary fistula opening,any associated tracts, or any secondary openings without a change in continence.
The simplest analfistulae are treated using fistulotomy with a high rate of recurrences and other morbidities. Complexfistulae management poses increased risk of a change in continence and higher chances of recurrenceswhich forced the surgeons to search for a better option.Various modalities like cutting seton,advancement flap, fibrin glue injection, fistula plug,ligationofintersphincteric fistula tract (LIFT), orBioLIFT (LIFT technique with a variation) are being tried to overcome the hardship faced by the
patients.Hence this pilot study is put forward to assess the therapeutic efficacy of Pancha paadanachendooram and Meni thylam which are indicated for Powthiram (Fistula in ano) condition as perclassical Siddha Literature in management of fistula in ano.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient who will fulfil following criteria will be included in this study:
- •Age: 18 to 60 years.
- •Patients diagnosed with the condition of low anal fistula having single tract of length not more than 8 cm
- •Fistula patients of less than 3 years duration
- •Willingness of the patient to give blood and urine samples and cooperate by strictly complying with the medical advice of the research team.
- •Patients who had not undergone previous surgery for fistula.
排除标准
- •H/o Tuberculosis ï‚·Uncontrolled metabolic disorders ï‚· H/o Hepatitis B & C.
- •ï‚· H/o Haemophilia and bleeding disorders.
- •ï‚· H/o Pregnancy & Lactation.
- •ï‚· H/o Uncontrolled diabetes ï‚· H/o coronary heart diseases and other cardiac ailments.
- •ï‚· H/o AIDS, Syphilis.
- •ï‚· H/o Crohn’s disease.
- •ï‚· High anal fistula and complicated fistula ï‚· H/o Rectal prolapse ï‚· H/o rectal carcinoma.
结局指标
主要结局
1. Number of patients achieved a Zero score of Peri Anal Disease Activity
时间窗: 90 days
Index (PDAI).
时间窗: 90 days
次要结局
- Duration taken for healing will be analyzed and described with respect(to the length of the tract and duration of the condition prior to the)