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.Keywords: Ankaferd, Bleeding, Hemostasis, Hemorrhagic diathesis, Phase I trial
ÖZET Topikal Ankaferd Hemostat'›n Güvenilirli¤ini Yans›tan Sa¤l›kl› Gönüllülerde Yap›lm›fl Plasebo Kontrollü, Randomize, Çift Kör, Çapraz Geçiflli Faz-I Klinik Çal›flmaAnkaferd, geleneksel Türk t›bb›nda hemostatik ajan olarak kullan›lan bir bitkisel bilefliktir. Ankaferd Hemostat (ABS, Ankaferd BloodStopper®) Thymus vulgaris, Glycyrrhiza glabra, Vitis vinifera, Alpinia officinarum ve Urtica dioica bitkileri ABS içeri¤inde yer almaktad›r. ABS hemostatik etkileri, literatürde in vitro ve in vivo çal›flmalarda gösterilmifltir. ABS'nin temel etki mekanizmas›, canl› eritroid aggregasyon için fokal odaklar teflkil eden bir protein a¤›n›n oluflturulmas›na dayanmaktad›r. Topikal ABS'nin insanlarda bir hemostatik ajan olarak etkinlik ve güvenilirlili¤ine iliflkin ilk bulgular, klinik kanamalar ve dental giriflimlerdeki ABS kullan›m verilerine dayanmaktad›r. Bu çal›flman›n amac›; randomize, çift-kör, çapraz geçiflli, plasebo-kontrollü, bir çal›flma ile sa¤l›kl› gönüllülerde topikal ABS'nin güvenilirlili¤ini araflt›rmakt›r. Yirmi dört sa¤l›kl› gönüllü (11 erkek ve 13 kad›n, 18-44 yafllar›nda) çal›flma protokolü ile uyumlu olarak çal›flmaya al›nm›fllard›r. Çal›flma sonuçlar›na göre 120 dakikal›k topikal ABS uygulamas› lokal cilt etkileri ve sistemik laboratuvar testleri yönünden plasebo uygulamas›ndan farks›z sonuçlar vermifltir. Bu verilere dayanarak insanlarda topikal ABS uygulamas›n›n güvenilir oldu¤u sonucuna var›lm›flt›r.