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

Oral Submucous Fibrosis Clinical Trial

Official title:

Topical Application of Curcumin Incorporated in Orabase in OSMF Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02645656
• Other study ID #: SVSIDS/OMR/EX1/2013
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 29, 2015
• Last updated: January 4, 2016
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: January 2016
• Source: SVS Institute of Dental Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Ethics Commitee: India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Oral Submucous Fibrosis

Intervention

Drug:
• Curcumin Arm
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals

Locations

Country	Name	City	State
India	SVS Institute of Dental Sciences, Mahabubnagar	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Jaw Opening	Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.	up to 6 months	No