A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of aflapin in subjects with osteoarthritis of knee

Abstract

Aflapin(®) is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is more efficacious as an anti-inflammatory agent compared to the existing Boswellia products, 5-Loxin(®) and traditional 65% Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin(®) in the management of clinical symptoms of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN69643551). Sixty eligible OA subjects selected through screening were included in the study. The subjects received either 100 mg (n=30) of Aflapin(®) or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin. The observations suggest that Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin is a safe, fast acting and effective alternative intervention in the management of OA.

Keywords: Aflapin; Boswellia serrata; Clinical study; Osteoarthritis; Visual Analog Scale.

Figure 1

Flow chart of the subjects who participated in the clinical trial. Evaluations of physical activity and pain scores, serum biochemistry, hematology, urine biochemistry and pro-inflammatory biomarkers were done at baseline (day 0) and on days 5, 15 and 30 during follow up.

Figure 2

Pain, Function and stiffness scores. Presented are the mean scores for (a) visual analog scale, (b) Lequesne's Functional Index, (c) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-pain, (d) WOMAC-stiffness, and (e) WOMAC-function in placebo and 100 mg/day Aflapin® groups at different time points day 0, day 5, day 15 and day 30. Each bar represents mean ± standard deviation. In comparison with placebo the mean scores in the treatment groups were tested for significance using Wilcoxon's rank-sum test; * p < 0.05 and # p < 0.01.