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

Topical Application of Curcumin Incorporated in Orabase in OSMF Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02645656

Enrollment

Registered

2016-01-05

Start date

2013-12-31

Completion date

2016-02-29

Last updated

2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Submucous Fibrosis

Keywords

Oral Submucous Fibrosis, Curcumin

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.

Interventions

DRUGCurcumin Arm

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction in OSMF lesion	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

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026