跳至主要内容
临床试验/CTRI/2025/11/097993
CTRI/2025/11/097993尚未招募不适用

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

Dr Darshan Patil1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年12月10日最近更新:

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

发起方
Dr Darshan Patil
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Darshan Patil

Sri Sri College of Ayurvedic Science and Research

研究点 (1)

Loading locations...

相似试验