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

January 4, 2016 updated by: Dr R Viswa Chandra, SVS Institute of Dental Sciences

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SVS Institute of Dental Sciences

Investigators

  • Study Director: Ramaraju Devaraju, MDS, Academic Commitee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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