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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Dr R Viswa Chandra, SVS Institute of Dental Sciences

Tracking Information
First Submitted Date  ICMJE December 29, 2015
First Posted Date  ICMJE January 5, 2016
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
Jaw Opening [ Time Frame: up to 6 months ]
Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)
Official Title  ICMJE Topical Application of Curcumin Incorporated in Orabase in OSMF Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oral Submucous Fibrosis
Intervention  ICMJE Drug: Curcumin Arm
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals
Study Arms  ICMJE Experimental: Curcumin Arm
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.
Intervention: Drug: Curcumin Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 4, 2016)
30
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02645656
Other Study ID Numbers  ICMJE SVSIDS/OMR/EX1/2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will be released after publishing the findings.
Responsible Party Dr R Viswa Chandra, SVS Institute of Dental Sciences
Study Sponsor  ICMJE SVS Institute of Dental Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ramaraju Devaraju, MDS Academic Commitee
PRS Account SVS Institute of Dental Sciences
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP