Efficacy of Curcumin in Oral Submucous Fibrosis

Oral Submucous Fibrosis Clinical Trial

— ECOSMF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511261
• Other study ID #: HKESSNDCG/OMR/2014/CT1
• Status: Recruiting
• Phase: Phase 2
• First received: January 27, 2017
• Last updated: April 17, 2018
• Start date: January 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
• Contact: Jayashree Mudda, MDS
• Phone: +919741804012
• Email: jayashreemudda[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Oral Submucous Fibrosis

Intervention

Drug:
• 10% Curcumin mucoadhesive gel
Group 1 10%of mucoadhesive gel for topical application two times per day.
• Curcumin capsules 500mg
Group 2 curcumin 500 mg capsules for oral intake two times per day
• 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
• Placebo capsule
Group 4 placebo capsules for oral intake two times per day

Locations

Country	Name	City	State
India	HKE'S S.N Institute of dental sciences & research center	Gulbarga	Karnataka

Sponsors (1)

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

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burning sensation and pain	Visual Analogue Scale	6 months for each patient
Secondary	Interincisal distance, tongue protrusion and cheek flexibility	All these will be measured in mm at designated time intervals using digital vernier calliper.	6 months for each patient