An Open-label Prospective Noncomparative Clinical Study to Evaluate the Efficacy and Safety of Beliv: An Ayurvedic Medicine in Improving Liver Function

ABSTRACT

An open-label prospective noncomparative study was conducted to examine the efficacy and safety of Beliv tablet, a polyherbal Ayurvedic medicine, in 30 adult patients suffering from liver disorders. Two tablets were administered daily for 56 days. Patients were evaluated at Day 0, Day 21, Day 42 and at Day 56. The primary end point of the study was a change in liver function test parameters measured by the levels of serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and total bilirubin at all assessment points. Results showed a significant reduction in the serum levels of SGOT, SGPT and total bilirubin from baseline to 21 days, 42 days and 56 days. The total icterus symptom score was also significantly reduced from 5.17 ± 2.26 (baseline) to 2.6 ± 1.48, 1.37 ± 1.13 and 0.77 ± 0.73 at Days 21, 42 and 56, respectively. The Subjective Global Assessment (SGA) decreased significantly from 3.33 ± 1.16 (Day 21) to 2.33 ± 1.16 and 1.80 ± 0.76 at Days 42 and 56, respectively. The Physician Global Assessment (PGA) score was also significantly reduced from 3.0 ± 1.02 (Day 21) to 2.07 ± 0.83 and 1.70 ± 0.79 at Days 42 and 56, respectively. A significant reduction in serum creatinine level was observed at Day 56. No adverse effects or serious adverse effects were observed during the study period. The study concluded that Beliv tablet was highly effective for the treatment of liver disorders, as evidenced by the reduction in serum levels of SGOT, SGPT, total bilirubin, icterus symptoms and PGA and SGA scores. No treatment-related side effects were reported by any of the study participants suggesting that it was safe for clinical use in humans for the treatment of liver disorders.