Efficacy of Curcumin in Oral Submucous Fibrosis

Last updated: April 17, 2018
Sponsor: H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
Overall Status: Trial Status Unknown

Phase

2

Condition

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT03511261
HKESSNDCG/OMR/2014/CT1
  • Ages 14-45
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 200 clinical stage 2 OSMF patients

Exclusion

Exclusion Criteria:

  • Clinical stage 1 & 3 OSMF patients, oromucosal disorders with clinical features sameas OSMF, patients who are under treatment, clinically diagnosed cases not ready forincisional biopsy, patients suffering from medically compromised conditions.

Study Design

Total Participants: 200
Study Start date:
January 01, 2014
Estimated Completion Date:
December 31, 2018

Study 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.

Connect with a study center

  • HKE'S S.N Institute of dental sciences & research center

    Gulbarga, Karnataka 585102
    India

    Active - Recruiting

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