A Randomized Multicentric, Placebo-controlled, Parallel, Double-blinded clinical trial to evaluate the efficacy of Svarnsaathi (a proprietary formulation enriched with curcumin) in the treatment of Oral Sub-Mucous Fibrosis

Oral submucous fibrosis (OSMF) is a precancerous condition that is associated with significant functional morbidity and an increased risk for malignancy. It initially affects the lamina propria of the oral mucosa and as the disease progresses it involves the submucosa and the deeper tissues including muscles of the oral cavity with resulting loss of fibro-elasticity. The clinical manifestations include blanching and stiffening of the oral mucosa leading to limitation in oral opening. The presence of fibrous bands in lips, cheeks and soft palate is a hallmark of the disease. The disease extends over time to include the oropharynx and the upper third of the oesophagus. The etiology of the disease over the intervening years was thought to be multifactorial and several agents have been implicated, including the consumption of large amounts of chillies, chronic iron, vitamin B-complex deficiency, anaemia, nutritional deficiencies, genetic predisposition, and auto-immune disease, in addition to the mentioned etiologies, the other local irritants like tobacco (smoking and non smoking). The custom among Indians of chewing "pan" (betel leaf with tobacco powder and other ingredients) and also habit of areca nut /Gutkha chewing has led to the assumption that these habits are also the cause of submucous fibrosis. Several pathogenic mechanisms have been proposed, all based on the constituents of areca nut and genetic susceptibility to the disease. Reports on the frequency of encountering OSMF suggests that the disease has rapidly increased in India from an estimated 250,000 in 1980 to 2 million cases in 1993. The reasons for this rapid increase of the disease is believed to be attributed to the commercial marketing strategies of the pan masala industry which produces and markets freeze-dried preparations of areca nut, and the growth in uptake of this habit by young people (Gupta, 1999). Various classification systems for OSMF based on clinical (Warnakulasuriya, 1987), (Maher et al., 1996) and histopathological criteria (Pindborg & Sirsat, 1966) exist. There are no established markers to identify who may be predisposed to the disease nor to identify the risk of malignancy in affected individuals.