A 3 month clinical trial of herbal medicine combination intended for topical application in patients with leg symptoms complaints due to chronic venous insufficiency: a double-blind randomized controlled trial

INTERVENTION: 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 participant was given a herbal medicine combination gel formulation containing 2% acetyl salicylic acid in bees wax encapsulation and 2% asiaticoside plus 1% acemannan. It was applied to the leg with symptoms once in the morning and then again at bedtime continuously for 3 months. 2. Control treatment arm: each participant was given a controlled‐gel with identical odour and colour with no active herbal drugs. It was applied to the leg with symptoms once in the morning and then again at bedtime continuously for 3 months. Previous interventions: Participants fulfilling the eligibility criteria were randomly allocated into one of two arms. 1. Active treatment arm: each participant was given a herbal medicine combination gel formulation containing 2% acetyl salicylic acid in bees wax encapsulation and 2% asiaticoside plus 1% acemannan. It was applied to the leg with symptoms once in the morning and then again at bedtime continuously for 3 months. 2. Control treatment arm: each participant was given a placebo‐gel with identical odour and colour with no active herbal drugs. It was applied to the leg with symptoms once in the morning and then again at bedtime continuously for 3 months. CONDITION: Chronic venous insufficiency ; Circulatory System ; Venous insufficiency (chronic) (peripheral) PRIMARY OUTCOME: 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 OUTCOME: 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 ; 4. Assessment of overall physical functions, measured at baseline, week 1, week 2, week 3, week 4, week 8 and week 12 ; 5. Laboratory blood chemistry and alanine aminotransferase enzyme assessments, measured at baseline, week 1, week 2, week 3, week 4, week 8 and week 12 ; 6. Symptoms reported by patients, assessed by the Patients Self‐Rated Symptoms Scale (VAS) in a weekly diary report 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<