Oral Submucous Fibrosis Clinical Trial
Official title:
Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.
The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF).
200 clinical stage 2 OSMF patients selected randomly by simple random technique with
clinically & histopathologically confirmed diagnosis are divided into 4 groups with 50
patients each.
In Group 1 patients are given 10% of curcumin mucoadhesive gel and are instructed to use it
topically twice daily making it a daily dose of 1gm.
In Group 2 patients are given 500mg of curcumin capsules and are instructed to take 2
capsules twice daily making a daily dose of 1gm.
In Group 3 patients will be given 5% of curcumin mucoadhesive gel and will be instructed to
use it topically twice daily & 250mg of curcumin capsules to be taken twice daily making it a
daily dose of 1gm.
Group 4 is considered as control group and provided with formulations without the active
drug.
The mean scores of 4 groups will be statistically tested using Anova technique.
The differences in clinical parameters at 15 days, 1 month, 3 months & clinical &
histopathological paramerters at 6 months will be compared between groups 1, 2, 3 & 4 by
using students 't' test & correlation is also used for knowing the association of variables.
For all tests, a 'p' value of 0.05 or less will be utilized for statistical significance.
Other non parametric tests can also be applied where ever necessary for data analysis.
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