Comparative Evaluation of Expression of Markers of Proliferation, Angiogenesis, & Apoptosis in OSMF before and after treatment with Polyherbal Preparation – Study protocol

Abstract

India alone accounts for one third of the world’s oral cancer and has a high rate of Oral Potentially Malignant
Diseases (OPMD) amongst Areca Nut & Tobacco Habitual. Oral submucous fibrosis (OSMF) is one of
the OPMDs which predominantly affect major population of South and Southeast Asia, especially Indian
subcontinent. Till date OSMF patients are treated symptomatically to relieve burning sensation, improve the
opening of mouth & tongue movements, reduce blanching and relieve from roughness of oral mucosa by
using various medicinal line of treatment i.e. vitamin A, lycopene, beta carotene and carotene analogs, but no
treatment is directed towards the reduction of malignant potential of preexisting OSMF cases. Thus, present
study will be conducted to compare the pre & post treatment serum level of proliferation, angiogenesis and
apoptosis inducing expression of markers with polyherbal therapy in oral submucous fibrosis. Methods:
Identification of clinically diagnosed patients of OSMF who will be divided into two groups by simple
random sampling procedure. Group-1 patients suffering from oral submucous fibrosis, will be receiving
Polyherbal Preparation while Group-2 patients receiving Lycopene. Pre and post treatment comparison for
clinical signs and symptoms and serum marker expressions for Proliferation, Angiogenesis, & Apoptosis in
both groups will be done and statistically analyzed. Results: Clinical signs and symptoms will be improved
with the present polyherbal protocol. Post treatment serum marker may favored reduction in proliferation,
angiogenesis and induced apoptosis which predicts malignant transformation. Conclusions: Polyherbal
therapy will help to reduce the malignant conversion without toxic effect on other system of the human body