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Efficacy of Curcumin in Oral Submucous Fibrosis (ECOSMF)

Primary Purpose

Oral Submucous Fibrosis

Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
10% Curcumin mucoadhesive gel
Curcumin capsules 500mg
5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
Placebo capsule
Sponsored by
H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Submucous Fibrosis focused on measuring Oral submucous fibrosis, curcumin, potentially malignant disease

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HKE'S S.N Institute of dental sciences & research centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

10%Curcumin mucoadhesive gel

Curcumin capsules 500mg

5% Curcumin gel+Curcumin capsules 250mg

Placebo capsules

Arm Description

Drug: Curcumin arm Curcumin10% mucoadhesive gel Group 1 patients: Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months

Group 2 patients: Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months

Group 3 patients: Drug: 5% Curcumin mucoadhesive gel & Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months

Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months

Outcomes

Primary Outcome Measures

Burning sensation and pain
Visual Analogue Scale

Secondary Outcome Measures

Interincisal distance, tongue protrusion and cheek flexibility
All these will be measured in mm at designated time intervals using digital vernier calliper.

Full Information

First Posted
January 27, 2017
Last Updated
April 17, 2018
Sponsor
H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03511261
Brief Title
Efficacy of Curcumin in Oral Submucous Fibrosis
Acronym
ECOSMF
Official Title
Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
H.K.E.S's S.Nijalingappa Institute of Dental Science and Research

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Submucous Fibrosis
Keywords
Oral submucous fibrosis, curcumin, potentially malignant disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
four groups, each group with different formulations.
Masking
Participant
Masking Description
single blinded
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10%Curcumin mucoadhesive gel
Arm Type
Active Comparator
Arm Description
Drug: Curcumin arm Curcumin10% mucoadhesive gel Group 1 patients: Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months
Arm Title
Curcumin capsules 500mg
Arm Type
Active Comparator
Arm Description
Group 2 patients: Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Arm Title
5% Curcumin gel+Curcumin capsules 250mg
Arm Type
Active Comparator
Arm Description
Group 3 patients: Drug: 5% Curcumin mucoadhesive gel & Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Intervention Type
Drug
Intervention Name(s)
10% Curcumin mucoadhesive gel
Other Intervention Name(s)
curcuminoid
Intervention Description
Group 1 10%of mucoadhesive gel for topical application two times per day.
Intervention Type
Drug
Intervention Name(s)
Curcumin capsules 500mg
Other Intervention Name(s)
curcuminoid
Intervention Description
Group 2 curcumin 500 mg capsules for oral intake two times per day
Intervention Type
Drug
Intervention Name(s)
5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
Other Intervention Name(s)
curcuminoid
Intervention Description
Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Other Intervention Name(s)
non curcuminoid
Intervention Description
Group 4 placebo capsules for oral intake two times per day
Primary Outcome Measure Information:
Title
Burning sensation and pain
Description
Visual Analogue Scale
Time Frame
6 months for each patient
Secondary Outcome Measure Information:
Title
Interincisal distance, tongue protrusion and cheek flexibility
Description
All these will be measured in mm at designated time intervals using digital vernier calliper.
Time Frame
6 months for each patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayashree Mudda, MDS
Phone
+919741804012
Email
jayashreemudda@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syeda Arshiya Ara, MDS
Organizational Affiliation
HKE'S S.N Institute of dental sciences & research center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HKE'S S.N Institute of dental sciences & research center
City
Gulbarga
State/Province
Karnataka
ZIP/Postal Code
585102
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayashree Mudda, MDS
Phone
+919741804012
Email
jayashreemudda@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26604488
Citation
Hazarey VK, Sakrikar AR, Ganvir SM. Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial. J Oral Maxillofac Pathol. 2015 May-Aug;19(2):145-52. doi: 10.4103/0973-029X.164524.
Results Reference
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Efficacy of Curcumin in Oral Submucous Fibrosis

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