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Efficacy of Curcumin in Oral Submucous Fibrosis (ECOSMF)

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ClinicalTrials.gov Identifier: NCT03511261
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
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  ICMJE January 27, 2017
First Posted Date  ICMJE April 27, 2018
Last Update Posted Date April 27, 2018
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
Burning sensation and pain [ Time Frame: 6 months for each patient ]
Visual Analogue Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Curcumin in Oral Submucous Fibrosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE Oral Submucous Fibrosis
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jayashree Mudda, MDS +919741804012 jayashreemudda@gmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03511261
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP