Health Condition 1: I838- Varicose veins of lower extremities with other complications
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of either sex with primary CVD with grades C4 C6 on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification. 2. 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: 1. Participants with vascular disease other than CVD, moderate and severe anemia, neurological, dermatological, and orthopedic disorders (that may mimic venous symptoms). 2. Participants with lower limb oedema due to cardiac, renal or hepatic diseases or participants with lower limb arterial disease. 3. Smokers, concomitant or previous history of addiction to alcohol or drug abuse, pregnant women, lactating women, and those who have undergone vein surgery recently. 4. Participants with clinically significant renal disease, hepatic disease, cardiovascular disease, psychological diseases (anxiety, depression etc.), and participants on medications hampering skin healing. 5. Participants in whom there will be a likelihood of being lost for follow-up or moving out of the state within the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Venous Clinical Severity Score (VCSS)Timepoint: Baseline, Day 30, Day 60 & Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in quality of life (QoL) assessed by Global Index Score (GIS) calculated through Chronic Venous Insufficiency Questionnaire (CIVIQ-20) questionnaireTimepoint: Baseline & Day 90;Duration of symptom-free period: Duration of symptom-free period after cessation of the 3-month intervention. The patient will be observed for 3 months to determine if further standard care is required, such as compression stockings or additional sessions of SiravyadhaTimepoint: 180th day;Any type of mild, moderate, and severe adverse events during the study period will be recorded.Timepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Pratap Shankar K M
National Ayurveda Research Institute for Panchakarma
Outcome results
None listed