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

NCT ID: NCT02645656

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-02-29

Brief Summary

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

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.

Conditions

Oral Submucous Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Curcumin Arm

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

Group Type: EXPERIMENTAL

Curcumin Arm

Intervention Type: DRUG

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

Interventions

Curcumin Arm

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SVS Institute of Dental Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr R Viswa Chandra

Ethics Committee Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramaraju Devaraju, MDS

Role: STUDY_DIRECTOR

Academic Commitee

Locations

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, India

Countries

India

Other Identifiers

SVSIDS/OMR/EX1/2013

Identifier Type: -

Identifier Source: org_study_id