Health Condition 1: null- Patients of unilateral varicose veins-leg Having SVT in affected superficial veins confined to varicosities without any DVT
Conditions
Interventions
Intervention1: Heparin Sodium 1000 IU/ ml: Each ml of topical solution contains 1000 IU equivalent heparin sodium
Dose 1000 IU/ml
Route Topical
Frequency three times a day
Total Duration treatment per
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 3 months 10 Known hypersensitivity to heparin or history of heparin-induced thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Each group of test arm will be compared to other two groups of test arm as well as to corresponding group in placebo arm for Median reduction in thrombus length Timepoint: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Median change in pain intensity measured by NRS Median change in severity of swelling measured by 4-point scale Mean number of times rescue drug applied over treatment period Mean number of days with rescue drug application Timepoint: NA | — |
Countries
India
Contacts
Public ContactPratik Shah
Troikaa Pharmaceuticals Limited
Outcome results
None listed