Comparative Clinical Study In Fistula In Ano To Evaluate The Efficacy Of Ultramodern Mechanised Ksharasutra Thread And Traditional Ksharasutra Thread
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief from pain, pus discharge
研究概览
简要总结
Aim
To comparatively evaluate the efficacy of two different types of Ksharasutra threads - Mechanised Ksharasutra and Traditional Ksharasutra-in the management of fistula-in-ano.
Objectives
Primary Objectives
To evaluate the efficacy of Ultramodern Mechanised Ksharasutra in the management of Fistula-in-Ano.
To evaluate the efficacy of Traditional Ksharasutra in the management of Fistula-in-Ano.
Secondary Objectives
Assessment of Pain, Discharge, Itching and Swelling as subjective parameters.
Assessment of Unit Cutting Time (UCT) as an objective parameters.
Null Hypothesis (H0)
Ultramodern Mechanised Ksharasutra will not be Efficacious in healing of Fistula-in Ano as compared to Traditional Ksharasutra.
Alternate Hypothesis (H1)
Ultramodern Mechanised Ksharasutra will be equally efficacious in healing of Fistula-in-Ano as compared to Traditional Ksharasutra.
Alternate Hypothesis (H2)
Ultramodern Mechanised Ksharasutra will be more efficacious in healing of Fistula-in-Ano as compared to Traditional Ksharasutra.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical signs & symptoms of Bhagandara [Low Anal Fistula] Age: Between 20 to 60 years.
- •Fistula track not exceeding 3 cm in length.
- •Single Track Fistula.
排除标准
- •Age: Below 20 & Above 60 years.
- •High Anal Fistula.
- •Diabetic Patients.
- •HIV+ve, HBsAg+ve, VDRL+ve.
- •Secondary Fistula due to: i.
- •Ulcerative colitis, ii.
- •Chron’s disease, iii.
- •Tuberculosis, iv.
- •Carcinoma of Rectum & Anal canal.
结局指标
主要结局
Relief from pain, pus discharge
时间窗: 72 Days
次要结局
- Relief from swelling, itching(72 days)
研究者
Dr Kamal Anilbhai Patel
Department Of Shalya Tantra