Comparative Evaluation of the Efficacy of Shallakyadi Plaster and Standard POP in the Management of Simple Fractures of Long Bones of the Upper Limb: A Research Protocol

Abstract

Introduction: Fracture management is one of the wellestablished concepts in Ayurveda with numerous fracture healing drugs mentioned for topical application. The present study is an attempt to form a compound of few of those drugs which can be used as a plaster cast. The effect of this Herbomineral ayurvedic plaster cast on fractures would be studied both in aspects of immobilisation and fracture healing. Shallakyadi plaster which is a novel compound composed of resin of Boswellia serrata Roxb, resin of Acacia nilotica (Linn.) Willd.ex Del, root of Glycirrhiza glabra Linn, whole plant of Cissus quadrangularis Linn, Stem of Rubia cordifolia Linn, bark of Terminalia arjuna Wight & Arn (W&A), resin of Commiphorawightii Arn, Kaolinite (phyllosilicate of aluminium) and hydrated magnesium silicate can be used as a herbomineral ayurvedic compound for the healing of fractures. Need of Study: Standard Plaster of Paris (POP) cast has no therapeutic role on healing of fracture other than the purpose of immobilisation, whereas the drugs in Shallakyadi Plaster have known effects on bone healing and also provide the adequate immobilisation provided by Standard POP cast. Hence, the present study will compare the efficacy of Shallakyadi Plaster and Standard POP in the management of simple fractures of long bones of upper limb. Aim: To study and compare the efficacy of Shallakyadi plaster and standard POP in the management of simple fractures of long bones of upper limb. Materials and Methods: The present study is designed as a randomised control trial which would be conducted in Mahatma Gandhi Ayurveda College Hospital and Research Centre (MGACHRC), Salod Hirapur (H), Maharashtra, India for three months, in which 60 patients will be enrolled. Standard POP Plaster or Shallakyadi plaster will be applied for local application over the fractured area. Parameters like pain, swelling, loss of function, tenderness would be studied subjectively and callus formation would be taken as the objective parameter. Statistical analysis would be done using GraphPad Prism 7.0 V software and statistical tests- Chi-square test, Wilcoxon’s rank sum test and Wilcoxon’s signed rank test will be applied with level of significance as 0.05.