Chronic venous insufficiency Circulatory System Venous insufficiency (chronic) (peripheral)
Conditions
Interventions
Current interventions as of 15/12/2017:
Participants fulfilling the eligibility criteria were randomly allocated into one of two arms.
1. Active treatment arm: each par
Sponsors
National Research University Project, Office of the Higher Education Commission (WCU-58-034-AS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/12/2017: Patients seeking advice at the surgery ambulatory clinics with at least 5 of the following symptoms: 1. Heavy leg 2. Pain in the leg 3. Sensation of leg swelling 4. Night cramp 5. Itching leg 6. Sensation of burning 7. Sensation of pins/needle in the leg 8. Presence of superficial varicose vein 9. Presence of spider veins 10. Presence of blood-clotting. And must have been accurately diagnosed as chronic venous insufficiency by physician as per WHO- ICD10 Criteria and also being graded as appropriate staging of the chronic venous insufficiency stage as per the CEAP Criteria. Previous inclusion criteria: Patients seeking advice at the surgery ambulatory clinics with at least 5 of the following symptoms: 1. Heavy leg 2. Pain in the leg 3. Sensation of leg swelling 4. Night cramp 5. Itching leg 6. Sensation of burning 7. Sensation of pins/needle in the leg 8. Presence of superficial varicose vein 9. Presence of spider veins 10. Presence of blood-clotting. Plus these patients must have at least one risk factor as follows : 1. Sibling history with presence of swollen leg, spider & varicose veins and ankle/leg ulcer 2. Long hours standing per day (=3 hours) 3. Long hours sitting per day (=3 hours) 4. No regular exercise 5. Smoker 6. Taking hormone replacement therapy and/or contraceptive (oral/injectable) And must have been accurately diagnosed as chronic venous insufficiency by physician as per WHO- ICD10 Criteria and also being graded as appropriate staging of the chronic venous insufficiency stage as per the CEAP Criteria.
Exclusion criteria
Exclusion criteria: Patients with known history of: 1. ASA-exacerbated respiratory disease (AERD) and/or asthma 2. ASA-sensitivity and Rhinitis/Nasal Polyps 3. ASA and NSAIDs induce cutaneous reactions with Urticaria, Angioedema 4. ASA-induced anaphylactoid reactions with Hypotension, swelling, laryngeal edema, generalized pruritus, tachypnea also: 5. Patients with known sensitivity or allergic to centenella asiaticosa or asiaticoside. 6. Patients with known sensitivity or allergic to acemannan and the aloe vera products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/02/2019: Venous disease severity, assessed by the venous clinical severity score (VCSS) measured at baseline, week 4, week 8 and week 12 Previous primary outcome measure: Venous disease severity, assessed by the venous clinical severity score (VCSS) measured at baseline, week 1, week 2, week 3, week 4, week 8 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/02/2019: 1. Physician-rated disability, assessed by the Physician Rated Symptom Perception Score (PRSPS) at baseline, week 1, week 2, week 3, week 4, week 8 and week 12 2. Quality of life, assessed by the Chronic Venous Insufficiency Quality of Life Scale International Collaboration 14 questionnaires ( CIVIQ-14) and the Health-related Quality of Life Score Assessed with a Short-form 12-item Health Related Questionnaire Self-Administered Survey (SF-12). Measured at baseline and week 12 3. Patient-rated disability, assessed by the Patient Self-Rated Symptom Score (PSSS) at baseline, week 1, week 2, week 3, week 4, week 8 and week 12 4. Symptoms reported by patients, assessed by the Patients Self-Rated Symptoms Scale (VAS) in a weekly diary report Previous secondary outcome measures: 1. Disability caused by venous disease, assessed by the Venous Disease Disability Score (VDDS), measured at baseline, week 1, week 2, week 3, week 4, week 8 and week 12 2. Quality of life, assessed by the Chronic Venous Insufficiency Quality of Life Scale International Collaboration 14 questionnaires ( CIVIQ-14) and the Health-related Quality of Life Score Assessed with a Short-form 12-item Health Related Questionnaire Self-Administered Survey (SF-12). Measured at baseline and week 12 3. Assessment of overall physical functions, measured at baseline, week 1, week 2, week 3, week 4, week 8 and week 12 4. Laboratory blood chemistry and alanine aminotransferase enzyme assessments, measured at baseline, week 1, week 2, week 3, week 4, week 8 and week 12 5. Symptoms reported by patients, assessed by the Patients Self-Rated Symptoms Scale (VAS) in a weekly diary report | — |
Countries
Thailand
Outcome results
None listed