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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

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).

Condition or disease Intervention/treatment Phase
Oral Submucous Fibrosis Drug: 10% Curcumin mucoadhesive gel Drug: Curcumin capsules 500mg Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg Drug: Placebo capsule Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Official Title: Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

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 Name: 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 Name: 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 Name: 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 Name: non curcuminoid




Primary Outcome Measures :
  1. Burning sensation and pain [ Time Frame: 6 months for each patient ]
    Visual Analogue Scale


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511261


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

Locations
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India
HKE'S S.N Institute of dental sciences & research center Recruiting
Gulbarga, Karnataka, India, 585102
Contact: Jayashree Mudda, MDS    +919741804012    jayashreemudda@gmail.com   
Sponsors and Collaborators
H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
Investigators
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Principal Investigator: Syeda Arshiya Ara, MDS HKE'S S.N Institute of dental sciences & research center

Publications:
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Responsible Party: Syeda Arshiya Ara, Professor & Research scholar, H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
ClinicalTrials.gov Identifier: NCT03511261     History of Changes
Other Study ID Numbers: HKESSNDCG/OMR/2014/CT1
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Syeda Arshiya Ara, H.K.E.S's S.Nijalingappa Institute of Dental Science and Research:
Oral submucous fibrosis
curcumin
potentially malignant disease

Additional relevant MeSH terms:
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Fibrosis
Oral Submucous Fibrosis
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action