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

Primary Purpose

Oral Submucous Fibrosis

Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Curcumin Arm
Sponsored by
SVS Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Submucous Fibrosis focused on measuring Oral Submucous Fibrosis, Curcumin

Eligibility Criteria

22 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SVS Institute of Dental Sciences, Mahabubnagar

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Curcumin Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction in OSMF lesion
The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices.

Secondary Outcome Measures

Jaw Opening
Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.

Full Information

First Posted
December 29, 2015
Last Updated
January 4, 2016
Sponsor
SVS Institute of Dental Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02645656
Brief Title
Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)
Official Title
Topical Application of Curcumin Incorporated in Orabase in OSMF Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Submucous Fibrosis
Keywords
Oral Submucous Fibrosis, Curcumin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Curcumin Arm
Arm Type
Experimental
Arm Description
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.
Intervention Type
Drug
Intervention Name(s)
Curcumin Arm
Intervention Description
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals
Primary Outcome Measure Information:
Title
Reduction in OSMF lesion
Description
The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Jaw Opening
Description
Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramaraju Devaraju, MDS
Organizational Affiliation
Academic Commitee
Official's Role
Study Director
Facility Information:
Facility Name
SVS Institute of Dental Sciences, Mahabubnagar
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
509002
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be released after publishing the findings.

Learn more about this trial

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

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