Efficacy of Curcumin in Oral Submucous Fibrosis

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.

Conditions
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Oral Submucous Fibrosis

Intervention / Treatment
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* Drug: 10% Curcumin mucoadhesive gel
* Drug: Curcumin capsules 500mg
* Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
* Drug: Placebo capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 200 clinical stage 2 OSMF patients Exclusion Criteria: Clinical stage 1 & 3 OSMF patients, oromucosal disorders with clinical features same as OSMF, patients who are under treatment, clinically diagnosed cases not ready for incisional biopsy, patients suffering from medically compromised conditions.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: four groups, each group with different formulations.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10%Curcumin mucoadhesive gel<br>Drug: Curcumin arm Curcumin10% mucoadhesive gel Group 1 patients: Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months | Drug: 10% Curcumin mucoadhesive gel<br>* Group 1 10%of mucoadhesive gel for topical application two times per day.<br>* Other names: curcuminoid;|
| Active Comparator: Curcumin capsules 500mg<br>Group 2 patients: Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months | Drug: Curcumin capsules 500mg<br>* Group 2 curcumin 500 mg capsules for oral intake two times per day<br>* Other names: curcuminoid;|
| Active Comparator: 5% Curcumin gel+Curcumin capsules 250mg<br>Group 3 patients: Drug: 5% Curcumin mucoadhesive gel & Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months | Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg<br>* Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day<br>* Other names: curcuminoid;|
| Placebo Comparator: Placebo capsules<br>Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months | Drug: Placebo capsule<br>* Group 4 placebo capsules for oral intake two times per day<br>* Other names: non curcuminoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burning sensation and pain | Visual Analogue Scale | 6 months for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interincisal distance, tongue protrusion and cheek flexibility | All these will be measured in mm at designated time intervals using digital vernier calliper. | 6 months for each patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral submucous fibrosis, curcumin, potentially malignant disease