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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).
Full description
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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200 participants in 4 patient groups, including a placebo group
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Central trial contact
Jayashree Mudda, MDS
Data sourced from clinicaltrials.gov
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