Efficacy of Curcumin in Oral Submucous Fibrosis (ECOSMF)

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