Trial | NCT03511261  Report issue

Title

Efficacy of Curcumin in Oral Submucous Fibrosis
Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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).
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 Started
Jan 31
2014
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Apr 27
2018

Drug 10% Curcumin mucoadhesive gel

Group 1 10%of mucoadhesive gel for topical application two times per day.

  • Other names: curcuminoid

Drug Curcumin capsules 500mg

Group 2 curcumin 500 mg capsules for oral intake two times per day

  • Other names: 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 names: curcuminoid

Drug Placebo capsule

Group 4 placebo capsules for oral intake two times per day

  • Other names: non curcuminoid

10%Curcumin mucoadhesive gel Active Comparator

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 Active Comparator

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

5% Curcumin gel+Curcumin capsules 250mg Active Comparator

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

Placebo capsules Placebo Comparator

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

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.
No Results Posted