This will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, interventional study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 168
- 试验地点
- 6
- 主要终点
- Each group of test arm will be compared to other two groups of test arm as well as to corresponding group in placebo arm forMedian reduction in thrombus length
研究概览
简要总结
Varicose veins is a common superficial pathology that leads to serious complications like ulceration and irritating symptoms such as pain, pruritus, swelling, erythema etc. resulting in morbidity in large population. Unfractionated heparin and low molecular heparin have been the corner stone of conservative management of the symptoms of varicose veins. Some European published studies indicate that liposomal heparin spray gel, a topical heparin sodium product was effective in reducing symptoms of varicose thrombophlebitis and are also reported to reduce size of thrombus in varicose veins.
Based on this information Troikaa proposes the present study to identify effectiveness and safety of their marketed product heparin sodium topical solution (1000 IU/ ml) as add on therapy to SOC in the treatment of thrombophlebitis associated with varicose vein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Presenting with area of thrombophlebitis having tenderness erythema pain and swelling overlying the affected superficial vein Having SVT in affected superficial veins confined to varicosities without any DVT as confirmed at screening by Duplex USG Willing & able to comply with study requirements eg regular application of IP/wear elastic stocking and efficacy-safety evaluation schedule as indicated by written informed consent provided by the patient 2 If female of childbearing potential non-pregnant supported by negative urine pregnancy test at screening non-lactating and willing to maintain reliable birth control throughout the study.
排除标准
- •1 Multiple superficial vein thrombosis that require LMWH therapy 2 Bilateral varicose veins-leg 3 Suppuration or other indications of infection 4 Open wound/ breach of skin 5 Hospitalization or long confinement to bed 6 Recent within last 6 months history of thromboembolic event eg Pulmonary embolism deep vein thrombosis superficial thrombophlebitis treated surgically 7 Recent within last 6 months history of cancer or its treatment 8 Hepatic impairment SGPT/SGOT > 3 times ULN or renal impairment creatinine > 2 mg/dL 9 Patient with history of CKD or CKD confirmed by decrease in GFR<60 ml/min/1.73 m2 present for >3 months 10 Known hypersensitivity to heparin or history of heparin-induced thrombocytopenia.
结局指标
主要结局
Each group of test arm will be compared to other two groups of test arm as well as to corresponding group in placebo arm forMedian reduction in thrombus length
时间窗: NA
次要结局
- Median change in severity of tenderness measured by 4-point scale(Mean change in erythema area cm2 measured by manual planimetry Investigator will demarcate the area with erythema on transparent sheet and the area will be calculated in cm2 using graph paper)