An open labelled non-randomized phaseII clinical trial to evaluate the effectiveness of Mezhugu kalimbu(External therapy)in the management of Narambu kiranthi (varicose Ulcer)
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
- The outcome of the study will be assessed by reduction in the margins(size) of the wound and better healing.
研究概览
简要总结
This study is an open labelled non randomised phase II clinical trial to evaluate the effectiveness of MEZHUGU KALIMBU ( external therapy) in the management of NARAMBU KIRANTHI( varicose ulcer).This trial drug will be an external application for daily 15 days in 40 patients.The trial period of 24 moths will be carried out in government Siddha medical College and hospital, palayamkottai, Tirunelveli 627002, Tamilnadu,The outcome of the study will be assessed by reduction in the margins(size) of the wound and better healing.In clase of any adverse events is noticed and it will be referred to pharmacovigilence department,and 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
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient who are willing to take external therapy alone Patient who are willing for admission and stay in IPD or willing to attend OPD.
- •Patients who are willing to give blood samples for laboratory investigations.
排除标准
- •Pregnant and lactating women Severe renal, hepatic, cardiac disease Malignant ulcers Uncontrolled diabetes Syphilitic ulcers Ischemic ulcers Traumatic ulcers.
结局指标
主要结局
The outcome of the study will be assessed by reduction in the margins(size) of the wound and better healing.
时间窗: 15 days
次要结局
未报告次要终点
研究者
DHINAKARAN T
Government siddha medical College and hospital, palayamkottai