Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)
- Registration Number
- NCT02645656
- Lead Sponsor
- SVS Institute of Dental Sciences
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Curcumin Arm Curcumin Arm Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Jaw Opening up to 6 months Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.
Trial Locations
- Locations (1)
SVS Institute of Dental Sciences, Mahabubnagar
🇮🇳Hyderabad, Andhra Pradesh, India