A Placebo-Controlled, Randomized, Double-Blinded, Cross-Over Phase-I Clinical Study Indicating the Safety of Topical Ankaferd Hemostat in Healthy Volunteers

Abstract

Ankaferd is a folkloric medicinal plant extract which has historically been used as an hemostatic agent in traditional Turkish medicine. Ankaferd Hemostat (ABS, Ankaferd BloodStopper®) includes the plants of Thymus vulgaris, Glycyrrhiza glabra, Vitis vinifera, Alpinia officinarum and Urtica dioica. The hemostatic effects of ABS have been established in the in vitro and in vivo studies in the Literature. The basic mechanism of action for ABS is the formation of an encapsulated protein network representing the focal points for the vital erythroid aggregation. The topical usage of ABS as a hemostatic agent in clinical hemorrhages and during dental interventions provided the first clues about the safety and efficacy of ABS in humans. The aim of this study is to search topical safety of ABS in a phase I randomized, double-blinded, cross-over, placebo controlled clinical study in healthy volunteers. Twenty-four healthy volunteers (11 males and 13 females, aged 18-44 years) compatible with the study protocol were enrolled into the study. In this study, topical ABS application for 120 minutes is not different from the placebo, in terms of both the local skin findings and systemic laboratory tests. Based on those data, it is concluded that topical application of ABS is safe and tolerable in humans.