Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)

Study Overview
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Brief Summary
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Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.

Detailed Description
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Anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of NF-κB and COX-2 (increased levels of COX-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines IL-1b, IL-6, and TNF-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase C, that mediate inflammation and tumor-cell proliferation. Curcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. Antioxidants are implicated in the pathogenesis of OSMF and hence this preparation may be helpful in resolution of this lesion.

Official Title
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Topical Application of Curcumin Incorporated in Orabase in OSMF Patients

Conditions
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Oral Submucous Fibrosis

Intervention / Treatment
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* Drug: Curcumin Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included. Exclusion Criteria: Subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin Arm<br>Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals. | Drug: Curcumin Arm<br>* Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in OSMF lesion | The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jaw Opening | Jaw opening in mm will be measured at designated time intervals using an appropriate instrument. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Submucous Fibrosis, Curcumin