Efficacy and safety of Jatyadi Ghrita and Ashwini Mudra in Chronic Anal Fissure: An open-label prospective randomized controlled pilot study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in REALISE score at baseline, after 2 weeks, 4 weeks, and 8 weeks of treatment
研究概览
简要总结
This is an open label prospective randomized controlled trial approved by Institutional Ethical Committee, All India Institute of Medical Sciences, Bhubaneswar. The primary objective of the study is to establish the effectiveness and safety of topical Jatyadi Ghrita and Ashwini Mudra practice in chronic anal fissures. All the eligible patients based on inclusion and exclusion criteria will be enrolled after taking of written consent. Total 66 patients will be divided into three groups and treated with topical Jatyadi Ghrita ointment, topical Jatyadi Ghrita ointment with the practice of Ashwini Mudra and topical nifedipine 0.3% and lidocaine 1.5% cream twice daily for 8 weeks for three separate groups. The primary outcomes will be change in REALISE score at baseline, after 2 weeks, 4 weeks, and 8 weeks of treatment.
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
- 16.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Willing to participate.
- •The age should be 16 to 60 years
- •Gender will be both male and female
- •Patients with a diagnosis of chronic anal fissure who had symptoms for more than 6 weeks.
- •Patients whose symptoms are not resolved by stool softeners, high fiber diet, warm sitz bath, etc.
- •A physical examination will show an anal ulcer with indurated edges and/or skin tag.
- •The VAS score should be between 3 to 7.
排除标准
- •History of reaction to topical agents.
- •Patients whose symptoms resolved within 6 weeks by stool softeners, high fiber diet, and warm sitz bath.
- •Patient with multiple anal fissures.
- •Patients suffering from severe anemia, carcinoma, chrons disease, ulcerative colitis, diabetes mellitus, hypertension, and HIV.
- •Pregnant women
- •Tuberculous ulcers and leukemic ulcers should be excluded.
- •Patient with perianal abscess, anal fistula, and third and fourth-degree hemorrhoids.
- •Chronic anal fissure patients with severe pain (VAS more than 7) and excessive bleeding per anum should be excluded.
结局指标
主要结局
Change in REALISE score at baseline, after 2 weeks, 4 weeks, and 8 weeks of treatment
时间窗: Baseline, 2 weeks, 4 weeks and 8 weeks of treatment.
次要结局
- Healing period of chronic anal fissure.(Adverse events during treatment.)
研究者
Ajit Kumar Pradhan
All India Institute of Medical Sciences Bhubaneswar