Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)
|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
|Condition or disease||Intervention/treatment||Phase|
|Oral Submucous Fibrosis||Drug: Curcumin Arm||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Topical Application of Curcumin Incorporated in Orabase in OSMF Patients|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2016|
Experimental: Curcumin Arm
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.
Drug: Curcumin Arm
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals
- 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.
- Jaw Opening [ Time Frame: up to 6 months ]Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645656
|SVS Institute of Dental Sciences, Mahabubnagar|
|Hyderabad, Andhra Pradesh, India, 509002|
|Study Director:||Ramaraju Devaraju, MDS||Academic Commitee|