Clinical comparative study to evaluate the effect of polyherbal muco adhesive patch and pratisarana with Ashwagandadi lehya in the management of Oral Sub Mucosal Fibrosis

Oral sub mucous fibrosis (OSMF) is a chronic debilitating disease of the oral cavity characterized by inflammation and progressive fibrosis of the lamina propria and sub mucosa that results in marked rigidity and eventually inability to open the mouth.1 It manifests as blanching and stiffness of the oral mucosa, trismus, burning sensation in the mouth, intolerance to eating hot and spicy foods, repeated vesicular eruption and ulceration of the buccal mucosa, palate and pillars, loss of gustatory sensation. Habit of betel nut and tobacco chewing, excessive consumption of chilies and spices, genetic susceptibility, immune mediated process, smoking, drinking alcohol coupled with dietary deficiencies are thought to be the causative factors of the OSMF2 . Probably involved pathogenesis is stimulation of fibroblast production, increased collagen synthesis due to areca nut alkaloids mainly are coline along with stabilization of collagen structure by catechin and tannin contents of areca nut3 . 3 On analyzing the disease condition with Ayurvedic approach, it seems to be nearer to Vata-Pitta dominant chronic Sarvasara Mukharoga4 and needs to be treated at local as well as systemic level. Hence the herbal drugs like Yashtimadhu, Mandukaparni, Haridra , Kumari , Madhu have been selected due to their antiinflammatory, antioxidant, and anticancer properties and it suppresses the connective tissue growth and decreases cellular fibrogenic activity5 . The lesions are usually treated using topically by pratisarana, kavala and gandusha but current drug delivery systems seems inadequate and new ways of delivering these therapeutic agents directly to lesions are required. Controlled delivery of drugs to the oral mucosa is challenging because of moist mucosal surfaces, salivary flow and abrasive forces within the oral cavity. To overcome these obstacles it is planned to prepare polyherbal muco adhesive patch6 and compare its efficacy with Pratisarana in the management of Oral Sub Mucosal Fibrosis. Ashwagandadi lehya7 will be administered to both groups as rasayana