Efficacy of Curcumin in Oral Submucous Fibrosis

Phase 2

• Conditions: Oral Submucous Fibrosis
• Interventions: Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg; Drug: 10% Curcumin mucoadhesive gel; Drug: Curcumin capsules 500mg; Drug: Placebo capsule

• Registration Number: NCT03511261
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2017-01-27
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-17
• Last Update Submitted: 2018-04-17
• Study First Posted: 2018-04-27
• Last Update Posted: 2018-04-27
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
5% Curcumin gel+Curcumin capsules 250mg	5% curcumin mucoadhesive gel + Curcumin capsules 250 mg	Group 3 patients: Drug: 5% Curcumin mucoadhesive gel \& Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months
10%Curcumin mucoadhesive gel	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
Curcumin capsules 500mg	Curcumin capsules 500mg	Group 2 patients: Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Placebo capsules	Placebo capsule	Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months

Primary Outcome Measures

Name	Time	Method
Burning sensation and pain	6 months for each patient	Visual Analogue Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HKE'S S.N Institute of dental sciences & research center; 🇮🇳 Gulbarga, Karnataka, India