This trial is active, not recruiting.

Condition oral submucous fibrosis
Treatment curcumin arm
Phase phase 2
Sponsor SVS Institute of Dental Sciences
Start date December 2013
End date February 2016
Trial size 30 participants
Trial identifier NCT02645656, SVSIDS/OMR/EX1/2013


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.
curcumin arm
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals

Primary Outcomes

Reduction in OSMF lesion
time frame: up to 6 months

Secondary Outcomes

Jaw Opening
time frame: up to 6 months

Eligibility Criteria

Male or female participants from 22 years up to 45 years old.

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.

Additional Information

Official title Topical Application of Curcumin Incorporated in Orabase in OSMF Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by SVS Institute of Dental Sciences.