Efficacy of standardized extract of centella asiatica ECa 233 in the management of minor aphthous ulceration

Abstract

A randomized, single-blind, placebo controlled trial was conduted to evaluate the efficacy of an oral paste containing a standardized extract of centela asiatica on minor aphthous ulcer (MiRAU) in comparison to 10% triamcinolone (TA) oral paste. One hundred and twenty individuals, median age of 21 years, 37 males and 83 females, presented at least on MiRAU with an onset of no longer than 48 hours at entry (day 0) were recruitd by an announement to the public. They were randomy divided into 3 groups of treatment receiving placebo oral paste (control), 0.05% ECa 233 oral paste and 0.10% TA oral paste. Subjects were instructed to apply the medication by themselves 3 times a day for 10 days. In addition they were asked to make a daily recording of ulcer size, degree of pain and occurrence of new ulcer in a given daily booklet. Photograph was taken on day 0 and at the follow-up on day 3 and day 10. Initial mean ulcer size was 8.14 ± 0.75, 7.80 ± 0.66 and 8.74 ± 0.76 sq.mm and initial pain score assessed by a visual analog scale (VAS) was 6.53 ± 0.30, 6.63 ± 0,26 and 6.75 ± 0.29 in cotrol, 0.05% ECa 233 and 0.10% TA treated groups, respectively. Ulcer size in control group increased to its peak value on day 3 then gradually declined with mean time to complete healing of 8.65 ± 0.25 days. In contrast a prompt decrease was noted on day 1 and continued to decrease to reach a statistically significant difference from control on day 3 in both 0.05% ECa 233 or 0.10% TA treated group which accordingly exhibited complete healing in 6.63 ± 0.23 and 6.58 ± 0.25 days. Reduction of pain by 0.05% ECa 233 and 0.10% TA was clearly demonstrated on day 1 and pain score in both groups became significantly different from control group on day 3. In addition, no adverse effect was reported during the course of treatment of 11 days. Base on the results observed, 0.05% ECa 233 seems to be as effective as 0.10% TA in reducing the ulcer size as well as ulcer associated pain in MiRAU. Further study on the prevention of recurrence of MiRAU would strengthen the potential of ECa 233 as an effectve and safe alternative treatment of MiRAU.