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

SVS Institute of Dental Sciences

Status and phase: Unknown; Phase 2

Conditions: Oral Submucous Fibrosis

Treatments: Drug: Curcumin Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT02645656

SVSIDS/OMR/EX1/2013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 22 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Curcumin Arm

Experimental group

Description:

Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.

Treatment:

Drug: Curcumin Arm