A multicentre, randomized, double blind, placebo controlled pilot study to evaluate the efficacy and safety of colloidal Nano silver gel (SilverSol) in the treatment of bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis

Abstract

The study evaluated the efficacy and safety of colloidal nano silver gel (SilverSol Vagigel) (A patented technology from American Biotech Labs, USA) in combination with 0.2% lactic acid in the female subjects for the treatment of vaginal infections.This study was a multicenter, randomized, double-blind, placebo-controlled pilot study in which post-menarchal female subjects between 18 and 65 years of age clinically diagnosed with bacterial vaginosis and vulvovaginal candidiasis were enrolled. The participants were randomized to receive treatment with SilverSol Vagigel or placebo (vehicle) gel (both treatments as one 4 gm application inserted into the vagina with an applicator device, once daily at bedtime for internal use and 2 gm gel for local application to the vulva and vagina for external use twice daily for a period of 14 days). The primary endpoint evaluated was the proportion of subjects achieving clinical cure. The secondary endpoint was the proportion of subjects achieving microbiological cure at the end of the study visit. A total of 57 subjects were randomized in the study out of which 38 subjects were randomized in SilverSol Vagigel arm and 19 subjects were randomized in placebo arm. SilverSol Vagigel significantly improved cure rates of vaginal infections compared to placebo. The proportion of subjects achieving clinical cure of vaginal infections was higher i.e., 33 (86.84%) subjects in SilverSol Vagigel arm compared to 07 (41.18%) subjects in Placebo gel arm (p-value: 0.0009). The clinical cure rate with SilverSol Vagigel was 81.82% (P=0.1758) for bacterial vaginosis and 92.59% (P=0.0010) for vulvovaginal candidiasis patients at the end of the study. Overall SilverSol Vagigel treatment resulted in a significantly higher microbial cure of vaginal infections (P=0.0028) compared to placebo, with a microbial cure rate of 100% for bacterial vaginosis (P=0.0330) and 85.19% for vulvovaginal candidiasis (P=0.0097). No adverse events were reported in subjects treated with SilverSol Vagigel.Colloidal Nano Silver Gel (SilverSol Vagigel) was effective and safe in treating bacterial vaginosis and vulvovaginal candidiasis.