Clinical study on Bhagandara(Fistula-in-ano) and its management with Nimba Ksharasutra.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To study the patho-physiology of Bhagandara.
研究概览
简要总结
THIS A COMPARATIVE CLINICAL STUDY ON EFFICACY OF NIMBA KSHARASUTRA WITH APAMARGA KSHARASUTRA IN THE MANAGEMENT OF BHAGANDARA(FISTULA IN ANO).
A. According to the procedure stated above 60 patients will be selected for the study. B. Selected case will be immediately undergo clinical examination and pathological investigation to assess the presenting condition. C. Out of 60 patients, 30 patients will be treated with Nimba ksharasutra and categorized in Group-1 [G1]. D. Rest 30 patients will be treated with conventional Apamarga ksharasutra and categorized in Group-2[G2].
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •All diagnosed cases of Bhagandara i.e. Low Anal Fistula.
排除标准
- •Age below 20 years and above 60 years.
- •High Anal Fistula Tuberculosis Uncontrolled Hypertension Uncontrolled Diabetes mellitus Chronic or Acute Ulcerative colitis Crohns disease Ano rectal and other Malignancy Veneral diseases, AIDS and Hepatitis B Pregnancy.
结局指标
主要结局
1. To study the patho-physiology of Bhagandara.
时间窗: The length of tract and other sign and symptoms will be assessed on 14th,28th,56th days respectively.
2. To evaluate and assess the efficacy of the Nimba Ksharsutra in Fistula-in-Ano.
时间窗: The length of tract and other sign and symptoms will be assessed on 14th,28th,56th days respectively.
3. To introduce a less irritant,less pain and burning sensation,safe and best
时间窗: The length of tract and other sign and symptoms will be assessed on 14th,28th,56th days respectively.
alternative modality in the management of Bhagandara.
时间窗: The length of tract and other sign and symptoms will be assessed on 14th,28th,56th days respectively.
次要结局
- The length of tract and other sign and symptoms will be assessed .(14th,28th,56th days respectively.)
研究者
Dr Satish Mishra
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri