An open labelled non randomized phaseII Clinical trial to evaluate the effectiveness of KOWSIGAR KULAMBU PUGAI[EXTERNALTHERAPY] in the management of VELI MOOLAM[EXTERNAL HAEMORRHOID]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of pain, swelling, itching, soreness, bleeding and the lump size is assessed by using pain assessment tool and clinical assessments.
研究概览
简要总结
This study is an open labelled non randomized phase II clinical trial to evaluate the effectiveness of kowsikar kulambu pugai (external therapy) in the management of velimoolam(external haemorrhoid).the trial drug will be an external application of PUGAI for 7days in 40patients. The periods of 24months will be carried out in government siddha medical college and hospital palayamkottai tirunelveli 627002.The outcome will be an external therapy in kowsikar kulambu pugai towards the management of velimoolam(external piles) and expect the patients to be relieved from the symptoms. In case of any adverse events is noticed and it will be referred to pharmacovigilance department. Further management of patients will be given OPD patients.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having the symptoms of pain, lump hanging down outside of the anus, soreness, redness,bleeding during passing stools, swelling and itching around the anal orifice.
- •Patients who is willing to undergo necessary investigations.
- •Willing for admission in IPD for 7 days or willing to attend OPD regularly.
- •Patients who are willing to participate in this study with knowledge of potential risks and who are willing to sign the informed consent.
- •Patients who are willing to take external therapy only.
排除标准
- •Fistula in ano Anal fissure Colorectal cancer Ulcerative colitis Rectal prolapse Pregnancy Lactating mothers.
结局指标
主要结局
Reduction of pain, swelling, itching, soreness, bleeding and the lump size is assessed by using pain assessment tool and clinical assessments.
时间窗: 7 days
次要结局
未报告次要终点
研究者
Dr S DHEIVANI
Government siddha medical college and hospital palayamkottai