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

NCT02645656 | Unknown Phase 2 DMC

• 1 other identifier: SVSIDS/OMR/EX1/2013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Submucous Fibrosis

Keywords

Oral Submucous Fibrosis; Curcumin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Jaw Opening

  up to 6 months

Study Arms (1)

Curcumin Arm

EXPERIMENTAL

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

Drug: Curcumin Arm

Interventions

Curcumin Arm DRUG

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

Curcumin Arm

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included.

You may not qualify if:

• Subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

Location

MeSH Terms

Conditions

Oral Submucous Fibrosis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ramaraju Devaraju, MDS

  Academic Commitee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ethics Committee Investigator

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 5, 2016
• Study Start: December 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 5, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)