Clinical trial NCT03511261: Efficacy of Curcumin in Oral Submucous Fibrosis
Official title: Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Submucous Fibrosis
Keywords: Oral submucous fibrosis
curcumin
potentially malignant disease
Lead sponsor: H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: four groups, each group with different formulations.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Burning sensation and pain
timeFrame: 6 months for each patient
Secondary outcomes:
measure: Interincisal distance, tongue protrusion and cheek flexibility
timeFrame: 6 months for each patient
Other outcomes:
Locations:
city: Gulbarga
country: India
facility: HKE'S S.N Institute of dental sciences & research center
state: Karnataka
Study officials:
affiliation: HKE'S S.N Institute of dental sciences & research center
name: Syeda Arshiya Ara, MDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.