Safety and effectiveness of Arborium Plus® in the management of varicose vein: A prospective single-arm, clinical trial

Abstract

IntroductionVaricose veins are part of the spectrum of chronic venous disease contribute to a high burden on health care resources. Since there has been no effective standard medications for the management of varicose veins, attempts have been initiated to herbal-based medicines, that are safe and effective to relieve overall problematic symptoms of varicose vein. The present study aimed to investigate the safety and efficacy of Arborium Plus®, a patented oral liquid herbal formulation in the management of varicose vein. MethodsA prospective, open-label, pilot study was conducted in 42 patients. All the eligible patients were treated with 10 mL BD of Arborium Plus® for 12 weeks after the collection of baseline values. BMI, blood pressure, hemoglobin, IL-6, TNF-α, hs-CRP, lipid profiles, and venous clinical severity were recorded at baseline and after 12 weeks of the treatment. ResultsThe baseline parameters were compared after 12 weeks of treatment. There was a significant reduction (P < 0.05) in the levels of IL-6, TNF-α, and hs-CRP after the treatment with Arborium Plus®. Similarly, the mean VCS score was reduced significantly to 1.61 ± 0.12 from 2.51 ± 0.37 after the treatment. ConclusionThe present study demonstrates that the administration of Arborium Plus® resulted in a significant reduction of inflammatory mediators like IL-6, TNF-α, and hs-CRP. The venous clinical severity was reduced significantly after 12 weeks of the treatment of Arborium Plus® but future studies with a large sample size should be conducted for a longer duration to establish its potential use in the management of varicose vein. Ctri registration numberCTRI/2016/02/006689.