Efficacy of Curcumin in Oral Submucous Fibrosis (ECOSMF)

April 17, 2018 updated by: Syeda Arshiya Ara, H.K.E.S's S.Nijalingappa Institute of Dental Science and Research

Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.

The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

200 clinical stage 2 OSMF patients selected randomly by simple random technique with clinically & histopathologically confirmed diagnosis are divided into 4 groups with 50 patients each.

In Group 1 patients are given 10% of curcumin mucoadhesive gel and are instructed to use it topically twice daily making it a daily dose of 1gm.

In Group 2 patients are given 500mg of curcumin capsules and are instructed to take 2 capsules twice daily making a daily dose of 1gm.

In Group 3 patients will be given 5% of curcumin mucoadhesive gel and will be instructed to use it topically twice daily & 250mg of curcumin capsules to be taken twice daily making it a daily dose of 1gm.

Group 4 is considered as control group and provided with formulations without the active drug.

The mean scores of 4 groups will be statistically tested using Anova technique.

The differences in clinical parameters at 15 days, 1 month, 3 months & clinical & histopathological paramerters at 6 months will be compared between groups 1, 2, 3 & 4 by using students 't' test & correlation is also used for knowing the association of variables.

For all tests, a 'p' value of 0.05 or less will be utilized for statistical significance.

Other non parametric tests can also be applied where ever necessary for data analysis.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Gulbarga, Karnataka, India, 585102
        • Recruiting
        • HKE'S S.N Institute of dental sciences & research center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 200 clinical stage 2 OSMF patients

Exclusion Criteria:

  • Clinical stage 1 & 3 OSMF patients, oromucosal disorders with clinical features same as OSMF, patients who are under treatment, clinically diagnosed cases not ready for incisional biopsy, patients suffering from medically compromised conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10%Curcumin mucoadhesive gel

Drug: Curcumin arm Curcumin10% mucoadhesive gel

Group 1 patients:

Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months
Drug: 10% Curcumin mucoadhesive gel
Group 1 10%of mucoadhesive gel for topical application two times per day.
Other Names:
  • curcuminoid
Active Comparator: Curcumin capsules 500mg

Group 2 patients:

Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Drug: Curcumin capsules 500mg
Group 2 curcumin 500 mg capsules for oral intake two times per day
Other Names:
  • curcuminoid
Active Comparator: 5% Curcumin gel+Curcumin capsules 250mg

Group 3 patients:

Drug: 5% Curcumin mucoadhesive gel & Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months
Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day
Other Names:
  • curcuminoid
Placebo Comparator: Placebo capsules
Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Drug: Placebo capsule
Group 4 placebo capsules for oral intake two times per day
Other Names:
  • non curcuminoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burning sensation and pain
Time Frame: 6 months for each patient
Visual Analogue Scale
6 months for each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interincisal distance, tongue protrusion and cheek flexibility
Time Frame: 6 months for each patient
All these will be measured in mm at designated time intervals using digital vernier calliper.
6 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H.K.E.S's S.Nijalingappa Institute of Dental Science and Research

Investigators

  • Principal Investigator: Syeda Arshiya Ara, MDS, HKE'S S.N Institute of dental sciences & research center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKESSNDCG/OMR/2014/CT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe