Efficacy of Curcumin in Oral Submucous Fibrosis (ECOSMF)

• ClinicalTrials.gov Identifier: NCT03511261
• Recruitment Status: Recruiting
• First Posted: April 27, 2018
• Last Update Posted: April 27, 2018
• Sponsor: H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
• Information provided by (Responsible Party): Syeda Arshiya Ara, H.K.E.S's S.Nijalingappa Institute of Dental Science and Research

Tracking Information

• First Submitted Date: January 27, 2017
• First Posted Date: April 27, 2018
• Last Update Posted Date: April 27, 2018
• Study Start Date: January 2014
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2018)

Burning sensation and pain [ Time Frame: 6 months for each patient ]

Visual Analogue Scale

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 17, 2018)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Curcumin in Oral Submucous Fibrosis
• Official Title: Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.
• 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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

four groups, each group with different formulations.

Masking: Single (Participant)
Masking Description:

single blinded

Primary Purpose: Treatment

• Condition: Oral Submucous Fibrosis

Intervention

• Drug: 10% Curcumin mucoadhesive gel
  Group 1 10%of mucoadhesive gel for topical application two times per day.
  Other Name: curcuminoid
• Drug: Curcumin capsules 500mg
  Group 2 curcumin 500 mg capsules for oral intake two times per day
  Other Name: curcuminoid
• 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 Name: curcuminoid
• Drug: Placebo capsule
  Group 4 placebo capsules for oral intake two times per day
  Other Name: non curcuminoid

Study Arms

• 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

  Intervention: Drug: 10% Curcumin mucoadhesive gel
• Active Comparator: Curcumin capsules 500mg

  Group 2 patients:

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

  Intervention: Drug: Curcumin capsules 500mg
• 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

  Intervention: Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
• Placebo Comparator: Placebo capsules
  Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months
  Intervention: Drug: Placebo capsule

• Publications *: 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 17, 2018): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2018
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jayashree Mudda, MDS; +919741804012; jayashreemudda@gmail.com

• Listed Location Countries: India

Administrative Information

• NCT Number: NCT03511261
• Other Study ID Numbers: HKESSNDCG/OMR/2014/CT1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Syeda Arshiya Ara, H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
• Study Sponsor: H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
• Collaborators: Not Provided

Investigators

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

• PRS Account: H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
• Verification Date: April 2018