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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02645656
Recruitment Status : Unknown
Verified January 2016 by Dr R Viswa Chandra, SVS Institute of Dental Sciences.
Recruitment status was:  Active, not recruiting
First Posted : January 5, 2016
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
Dr R Viswa Chandra, SVS Institute of Dental Sciences

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.

Condition or disease Intervention/treatment Phase
Oral Submucous Fibrosis Drug: Curcumin Arm Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Application of Curcumin Incorporated in Orabase in OSMF Patients
Study Start Date : December 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

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

Primary Outcome Measures :
  1. Reduction in OSMF lesion [ Time Frame: up to 6 months ]
    The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices.

Secondary Outcome Measures :
  1. Jaw Opening [ Time Frame: up to 6 months ]
    Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02645656

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SVS Institute of Dental Sciences, Mahabubnagar
Hyderabad, Andhra Pradesh, India, 509002
Sponsors and Collaborators
SVS Institute of Dental Sciences
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Study Director: Ramaraju Devaraju, MDS Academic Commitee
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Responsible Party: Dr R Viswa Chandra, Ethics Committee Investigator, SVS Institute of Dental Sciences Identifier: NCT02645656    
Other Study ID Numbers: SVSIDS/OMR/EX1/2013
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be released after publishing the findings.
Keywords provided by Dr R Viswa Chandra, SVS Institute of Dental Sciences:
Oral Submucous Fibrosis
Additional relevant MeSH terms:
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Oral Submucous Fibrosis
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action