CTRI/2018/05/013701尚未招募2 期
This will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, interventional study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
研究者
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