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

Topical Application of Curcumin Incorporated in Orabase in OSMF Patients

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.

Study Overview

• Status: Unknown
• Conditions: Oral Submucous Fibrosis
• Intervention / Treatment: Drug: Curcumin Arm

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 509002
      • SVS Institute of Dental Sciences, Mahabubnagar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin Arm; Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.	Drug: Curcumin Arm; Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SVS Institute of Dental Sciences
• Investigators: Study Director: Ramaraju Devaraju, MDS, Academic Commitee

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Curcumin; Oral Submucous Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Fibrosis; Oral Submucous Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: SVSIDS/OMR/EX1/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be released after publishing the findings.