Health Condition 1: null- Patients with unilateral & bilateral varicose veins in the lower limbs
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.A potential subject willing to give written informed consent on his own or legally acceptable representative (LAR) /Impartial witness in case of Illiterate subject and comply with all study procedures. 2.Patients with unilateral & bilateral varicose veins in the lower limbs 3.Both male & female patients will be included.
Exclusion criteria
Exclusion criteria: 1.Lower limb varicose vein with deep vein thrombosis,vein calcification,venous ulcer, 2. Lower limb varicose vein with pregnancy 3. Lower limb varicose vein with per abdominal masses 4. Patients with systemic disorders. 5. Age below 20 years and above 60 years 6.Patients with the bleeding disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in the Venous Clinical Severity Score (VCSS)as compared to baseline in varicose vein patientsTimepoint: At Visit-2 (Day 30) and Visit-4 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects who achieve complete or partial response and assessed for overall responseto lower limb Doppler study and haematogical parameters as compared to baselineTimepoint: Visit-4 (Day 90);Safety of the study drug will be estimated from type, number, frequency and percentage of subjects with AE(s) Timepoint: During study period. | — |
Countries
India
Contacts
Interdisciplinary School of Indian System of Medicine,SRM University