Health Condition 1: I838- Varicose veins of lower extremities with other complications
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: a. Participants of either sex with primary CVD with grades C2â??C4 on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification. b. Participants capable of and freely willing to provide written informed consent prior to participating in the study and comply with the study protocol requirements.
Exclusion criteria
Exclusion criteria: a. Participants with vascular disease other than CVD, diabetes mellitus, anemia, malnourishment caused by systemic diseases; metabolic, neurological, dermatological and orthopedic disorders (that may mimic venous symptoms). b. Participants with lower limb oedema due to cardiac, renal or hepatic diseases; lower limb arterial disease; deep or superficial venous thrombosis (during the screening time or in the previous 3 months). c. Obese subjects (BMI >30), smokers, concomitant or previous history of addiction to alcohol or drug abuse, pregnant women, lactating women and who have undergone vein surgery recently. d. Participants with uncontrolled hypertension, clinically significant renal disease, hepatic disease and cardiovascular disease, psychological diseases (anxiety, depression etc.), active substance abuse and patients on medications hampering wound healing. e. Participants who have been using the trial intervention in the previous 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Venous Clinical Severity Score (VCSS)Timepoint: Baseline, week 4 and week | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life (QoL) assessed by Global Index Score (GIS) calculated through CIVIQ-20 questionnaireTimepoint: Baseline, week 4 and week 8;Reduction in pain assessed through Numeric Pain Rating Scale. Patients will be asked to circle the number between 0 and 10that fits best to their pain intensity.Timepoint: Baseline, week 4 and week 8;Change in mid-calf circumference of the affected leg/sTimepoint: Baseline, week 4 and week 8;Hemodynamic improvements assessed by Duplex scanning. The following factors will be assessed pre and post-treatment. a. Number of incompetent perforators b. Reflux time c. Competency of Sapheno Femoral Junction and Sapheno Popliteal Junction d. Size of Great Saphenous Vein and Short Saphenous VeinTimepoint: Baseline & 8th week;Adverse events Any adverse events recorded during the study periodTimepoint: 60 days | — |
Countries
India
Contacts
Public ContactPratap Shankar
Outcome results
None listed