Health Condition 1: I998- Other disorder of circulatory system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients of both genders between 18 and 70 years. Patient presenting a C1 to C4 venous disease grade of the lower limbs, according to the clinical component of the CEAP classification Doppler report showing evidence of GSV, SSV or perforator reflux)
Exclusion criteria
Exclusion criteria: Premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period Known allergy or hypersensitivity to any component of the study drug CEAP levels 5 & 6 Patient with venous disease requiring surgery / chemical endovenous sclerotherapy Patient suffering from a painful pathology other than the venous pain in the lower limbs Patient with history of venous thrombosis or thromboembolic disease within the 6 months before inclusion Patient with alteration of general condition incompatible with his / her participation in the trial Patient wishing to be pregnant in the 6 following months History of chronic drug intake, Opioid/drug addiction/alcoholism Psychiatric illness, CLD, COPD, CKD Pregnant patients or those wishing to be pregnant in the coming 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Venous Clinical Severity Score (VCSS)Timepoint: Baseline After 30 Days After 60 Days After 90 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change/decrease in venous refluxTimepoint: 1 year | — |
Countries
India
Contacts
Sir Ganga Ram Hospital