NCT03511261

Efficacy of Curcumin in Oral Submucous Fibrosis

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: H.K.E.S's S.Nijalingappa Institute of Dental Science and Research · Academic / Other
• Sex: All
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Submucous Fibrosis

Interventions

Type	Name	Description
DRUG	10% Curcumin mucoadhesive gel	Group 1 10%of mucoadhesive gel for topical application two times per day.
DRUG	Curcumin capsules 500mg	Group 2 curcumin 500 mg capsules for oral intake two times per day
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
DRUG	Placebo capsule	Group 4 placebo capsules for oral intake two times per day

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2018-04-27
• Last updated: 2018-04-27

Locations

1 site across 1 country: India