Heparin sodium topical solution 1000 IU/ ml in the treatment of thrombophlebitis associated with varicose vei
- Conditions
- Health Condition 1: null- Patients of unilateral varicose veins-leg Having SVT in affected superficial veins confined to varicosities without any DVT
- Registration Number
- CTRI/2018/05/013701
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>Timepoint: NA
- Secondary Outcome Measures
Name Time Method Median change in severity of tenderness measured by 4-point scale <br/ ><br>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 <br/ ><br>Median change in pain intensity measured by NRS <br/ ><br>Median change in severity of swelling measured by 4-point scale <br/ ><br>Mean number of times rescue drug applied over treatment period <br/ ><br>Mean number of days with rescue drug application <br/ ><br> <br/ ><br>Timepoint: NA