Efficacy of Curcumin in Oral Submucous Fibrosis

NCT03511261 | Unknown Phase 2 DMC

• 1 other identifier: HKESSNDCG/OMR/2014/CT1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Oral Submucous Fibrosis

Keywords

Oral submucous fibrosis; curcumin; potentially malignant disease

Outcome Measures

Primary Outcomes (1)

• Burning sensation and pain

  Visual Analogue Scale

  6 months for each patient

Secondary Outcomes (1)

• Interincisal distance, tongue protrusion and cheek flexibility

  6 months for each patient

Study Arms (4)

10%Curcumin mucoadhesive gel

ACTIVE COMPARATOR

Drug: Curcumin arm Curcumin10% mucoadhesive gel Group 1 patients: Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months

Drug: 10% Curcumin mucoadhesive gel

Curcumin capsules 500mg

ACTIVE COMPARATOR

Group 2 patients: Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months

Drug: Curcumin capsules 500mg

5% Curcumin gel+Curcumin capsules 250mg

ACTIVE COMPARATOR

Group 3 patients: Drug: 5% Curcumin mucoadhesive gel \& Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months

Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg

Placebo capsules

PLACEBO COMPARATOR

Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months

Drug: Placebo capsule

Interventions

10% Curcumin mucoadhesive gel DRUG

Group 1 10%of mucoadhesive gel for topical application two times per day.

Also known as: curcuminoid

10%Curcumin mucoadhesive gel

Curcumin capsules 500mg DRUG

Group 2 curcumin 500 mg capsules for oral intake two times per day

Also known as: curcuminoid

Curcumin capsules 500mg

5% curcumin mucoadhesive gel + Curcumin capsules 250 mg DRUG

Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day

Also known as: curcuminoid

5% Curcumin gel+Curcumin capsules 250mg

Placebo capsule DRUG

Group 4 placebo capsules for oral intake two times per day

Also known as: non curcuminoid

Placebo capsules

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• clinical stage 2 OSMF patients

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Kalaburagi, Karnataka, 585102, India

RECRUITING

Related 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.

  PMID: 26604488 BACKGROUND

MeSH Terms

Conditions

Oral Submucous Fibrosis

Interventions

Diarylheptanoids; Curcumin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Catechols; Phenols; Benzene Derivatives

Study Officials

• Syeda Arshiya Ara, MDS

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayashree Mudda, MDS

CONTACT

+919741804012; jayashreemudda@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Research scholar

Model Details: four groups, each group with different formulations.

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: April 27, 2018
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)