Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Size of oedema
研究概览
简要总结
Single centre ,Phase IV , interventional, The study includes :
200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
- Visit 1 : on day 1 to check patient eligibility and also for randomization .
- Visit 2 : on day 4 to assess target parameters
- Visit 3 : on day 8 to assess target parameters
- Visit 4 : on day 16 to assess target parameters
详细描述
Single centre ,Phase IV , interventional, The study includes :
* 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo .
The patients will be randomized to the active product (arm 1) or to placebo (arm 2).
The study consists of 4 visits as the following :
- Visit 1 : on day 1 to check patient eligibility and also for randomization .
- Visit 2 : on day 4 to assess target parameters
- Visit 3 : on day 8 to assess target parameters
- Visit 4 : on day 16 to assess target parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of patients between 20 and 60 years old.
- •Patients with all types of haematoma.
排除标准
- •Presence of infected wound requiring hospitalization or surgical intervention.
- •History of allergy or hypersensitivity to any of the ingredients.
- •Patients with coagulation disorders like haemophilia.
- •Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
- •Patients who are taking digestive enzymes like alfa chemotrypsin.
研究组 & 干预措施
Arm 1 : active product (Thrombexx)
100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment
干预措施: active product ( Thrombexx) assigned to arm 1 (Drug)
Arm 2 : Placebo
100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment
干预措施: Placebo assigned to arm 2 (Other)
结局指标
主要结局
Size of oedema
时间窗: 6 months
Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).
Severity of Pain
时间窗: 6 months
Assessment of pain severity will be by Vas score
Size of haematoma
时间窗: 6 months
Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.
Change in Colour
时间窗: 6 months
Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint
次要结局
未报告次要终点