Efficacy of kumari-karanja ksharasutra against apamarga ksharasutra in low anal fistula-an open label randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Unit cutting time
研究概览
简要总结
Fistula-in-ano is an inflammatory track lined by granulation tissue and fibrous tissue, which has an external opening in rectum, anal canal or skin around the perianal region. The prevalence of fistula-in-ano is higher due to lifestyle modifications. Patient frequently develop low anal fistula among the various types. Most fistula are thought to arise from cryptoglandular infections with resultant perianal abscess. The symptoms generally affect one’s quality of life from discomfort to infection due to drainage. The most effective surgical procedures now a days are fistulectomy and fistulotomy; nonetheless, there are certain post-operative problem such as incontinence and recurrence.
In ayurvedic perspective, bhagandara can be correlated with fistula-in-ano. A well proven therapeutic option for fistula-in-ano with a very low recurrence rate is ksharasutra application. Various combination of ksharasutra have been tried to develop for the management. In kumari based karanja ksharasutra, kumari has anti-inflammatory and wound healing properties. Karanja is a drug mentioned in ksharagana by Acharya susruta which has significant action in wound healing such as anti-inflammatory and anti-microbial.
The effect of kumari-karanja ksharasutra on cutting and healing of fistulous track along with pain and discharge against apamarga ksharasutra on 38 participants analyzing in the open label randomized controlled study with weekly changes in ksharasutra. Participants who meet inclusion criteria will be assigned to study group and control group, drawn from the OPD and IPD of Government Ayurveda College Hospital Kannur. Application of the Sutra will be done after baseline analysis of the participants. Assessment will be done based on objective parameters such as unit cutting time, healing effect and discharge, pain as subjective parameter, on the basis of scoring system. Collected data will be statistically analyzed and the study will be concluded.
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
- •Clinically diagnosed low anal fistula Participants with Written consent Age group.
- •20-60 years.
排除标准
- •Fistula in known cases of colorectal carcinoma, crohn’s, ulcerative colitis and tuberculosis Participants with uncontrolled Diabetes mellitus and Hypertension Known case of HIV, Hepatitis B and any venereal diseases Patient who are known case of severely compromised cardiopulmonary status Known cases of Bleeding disorder.
结局指标
主要结局
Unit cutting time
时间窗: 84 days/fistulous tract cut through
Healing time
时间窗: 84 days/fistulous tract cut through
Reduction in pain and discharge
时间窗: 84 days/fistulous tract cut through
次要结局
- Reduction in pain and discharge(84 days/fistulous tract cut through)
研究者
JANNATHUL SHERIN M
Government Ayurveda College Kannur