Efficacy of Curcumin in Oral Submucous Fibrosis (ECOSMF)

H

H.K.E.S's S.Nijalingappa Institute of Dental Science and Research

Status and phase

Unknown
Phase 2

Conditions

Oral Submucous Fibrosis

Treatments

Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
Drug: 10% Curcumin mucoadhesive gel
Drug: Placebo capsule
Drug: Curcumin capsules 500mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03511261
HKESSNDCG/OMR/2014/CT1

Details and patient eligibility

About

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).

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

14 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

200 participants in 4 patient groups, including a placebo group

10%Curcumin mucoadhesive gel
Active Comparator group
Description:
Drug: Curcumin arm Curcumin10% mucoadhesive gel Group 1 patients: Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months
Treatment:
Drug: 10% Curcumin mucoadhesive gel
Curcumin capsules 500mg
Active Comparator group
Description:
Group 2 patients: Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Treatment:
Drug: Curcumin capsules 500mg
5% Curcumin gel+Curcumin capsules 250mg
Active Comparator group
Description:
Group 3 patients: Drug: 5% Curcumin mucoadhesive gel & Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months
Treatment:
Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
Placebo capsules
Placebo Comparator group
Description:
Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Treatment:
Drug: Placebo capsule

Trial contacts and locations

1

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Central trial contact

Jayashree Mudda, MDS

Data sourced from clinicaltrials.gov

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