A Randomized Open Label Comparative Clinical Study To Evaluate The Role Of Laser Ablation Followed By Sapthacchada Pratisaraneeya Kshara Karma In The Management Of 2nd & 3rd Degree Internal Haemorrhoids - A Hybrid Technique
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
This Study Has been Taken Up To Evaluate The Role Of Laser Ablation Followed By Saptacchada Pratisaraneeya Kshara Karma In The Management Of 2nd & 3rd Degree Internal Haemorrhoids a Hybrid Technique
Null Hypothesis
H0 The Efficacy Of Hybrid Technique Is Better Than Kshara Karma & Laser Ablation Individually
H1 The Efficacy Of Kshara Karma Is Better Than Hybrid Technioque & Laser Ablation Individually
H2 The Efficacy Of laser Ablation is Better Than Hybrid Technique & Kshara Karma Individually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)(—)
入选标准
- •1.Subjects Aged Between 21 to 60 Years irrespective of Gender Religion Occupation Socioeconomic status and Educational Status 2.Subjects Who Fulfills The Diagnostic Criteria of 2nd & 3rd Degree Internal Haemorrhoids.
排除标准
- •1.Haemorrhoids associated with Rectal Prolapse Fistula in ano Thrombosed Pile Mass 2.Subjects Contraindicated For Kshara Shastra and Agnikarma 3.Haemorrhoids Associated With Carcinoma of Rectum and Anal canal 4.Subjects With Other Systemic Illness Like Tuberculosis Ulcerative colitis Chrons disease.
结局指标
主要结局
Primary Outcome
时间窗: 0th 3rd 5th 7th 14th and 21st day
Significant reduction in the
时间窗: 0th 3rd 5th 7th 14th and 21st day
1.Postoperative pain bleeding and discomfort
时间窗: 0th 3rd 5th 7th 14th and 21st day
2.Postoperative complications such as stenosis & Fecal incontinence
时间窗: 0th 3rd 5th 7th 14th and 21st day
3.Size of pile mass
时间窗: 0th 3rd 5th 7th 14th and 21st day
Seconday Outcome
时间窗: 0th 3rd 5th 7th 14th and 21st day
1.Lesser time duration of healing
时间窗: 0th 3rd 5th 7th 14th and 21st day
2.Minimal hospital stay
时间窗: 0th 3rd 5th 7th 14th and 21st day
3.Very low rate of recurrence due to dual outcome of both Kshara Karma and Laser Ablation
时间窗: 0th 3rd 5th 7th 14th and 21st day
次要结局
- 1.Lesser Time Duration Of Healing(2.Minimal Hospital Stay)
研究者
Dr Darshan Patil
Sri Sri College of Ayurvedic Science and Research
