Phase II non randomized open clinical evaluation of siddha medicine moolanoi chooranam for the management of ull moolam (internal haemorrhoids)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Outcome is assessed by reduction in clinical symptoms measured by haemorrhoids severity score scale.
研究概览
简要总结
Varicosities of the veins of the anal canal are known as haemorrhoids. Haemorrhoids may arise from internal or external around the anal canal. There are four degree where as first degree remain in rectum. Second degree prolapse through anus on defecation and spontaneously reduce but third degree requires digital reduction and fourth remains persistently prolapsed. Approximately 50 to 66% of people have haemorrhoids at some point in their lives.
The aim of the study is the management of ull moolam (internal haemorrhoids ) with siddha medicine moolanoi chooranam and the objective is to determine the therapeutic efficacy and safety profile of siddha medicine moolanoi chooranam in the management of ull moolam. As the literary evidence, hypothesis is created such a way for the efficacy of Moolanoi chooranam will be a better solution for ull moolam (internal haemorrhoids).
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with symptoms like constipation, bleeding during defecation, Pain in the anal region.
- •Grade 1 degree haemorrhoids.
排除标准
- •Second, third and fourth degree haemorrhoids, fissures in ano, fistula,CA rectum, rectal prolapse, pregnant and lactating mothers, Diabetes mellitus, Hypertension.
结局指标
主要结局
Outcome is assessed by reduction in clinical symptoms measured by haemorrhoids severity score scale.
时间窗: Primary outcome is assessed within 3 weeks.
次要结局
- Discharge cessation in bleeding during defecation.(Secondary outcome is assessed within 7 weeks.)
研究者
Aarthi G
Government siddha medical college chennai