Randomized Controlled Clinical Study To Evaluate The Efficacy Of Nimba Ksharsutra In The Management Of Bhagandar (Fistula-in-Ano).
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Veadana ,Daha , Kandu reduces after insertion of ksharsutra in fistula in ano on 7th day,14thday,21st day,28th day,35th day,42th day,49th day,56th day.
研究概览
简要总结
The Fistula usually originates from a perianal abscess in the Intersphincteric space of the anal canal from infection of the anal gland as the anal gland is situated deep to the internal sphincter to open in the Crypts of Morgagni situated on the dentate line. stasis and secondary infection lead to abscess formation and open into the anal canal and the abscess usually tracks down and opens in the perianal skin externally thus Fistula-in-Ano is formed.
Fistula-in-Ano is a track that has 2 opening external and internal. External opening is considered a secondary opening present at the perianal of the skin while Internal is considered a primary opening present in the anal canal.
The study will be conducted on 92 diagnosed patients of Bhagandar I.e., Fistula-in-Ano.
Screening of patients for inclusion
Initial Assessment for Patient Selection
Informed written consent
Randomization and group Allocation
Trial group (A) 46 Patients- Nimba Ksharsutra
Control group(B) 46 Patients -Apamarg Ksharsutra
Follow up for assessment (For a maximum of 8 weeks)
Observation & Results will be noted
Statistical analysis
Discussion and Conclusion
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
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •The Patient Age Group is 20-70 yr Patient Having low Anal Fistula in Ano Fistula In Ano Having Length less than equal to 4cm (including 4cm track).
排除标准
- •Patient Having High Anal fistula in Ano K/c/o.
- •Cancer of Rectum H/o Prolapsed Rectum Pregnant Women,AIDS,Hepatitis,TB Positive Patient Suffering From Uncontrolled DM,HTN.
结局指标
主要结局
Veadana ,Daha , Kandu reduces after insertion of ksharsutra in fistula in ano on 7th day,14thday,21st day,28th day,35th day,42th day,49th day,56th day.
时间窗: 56 days
次要结局
未报告次要终点
研究者
Dr Ganesh Uttamrao Asole
CSMSS Ayurved College kanchanwadi, Chhatrapati Sambhajingar Department of Shalyatantra opd no-16