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Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis

NCT06758739 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-03-06

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Curcumin is better than Intralesional Steroid Injection for the treatment of oral submucous fibrosis. The main question it aims to answers are:

1. If Curcumin is more effective to improve burning sensation as compared to Intralesional steroid.
2. Does Curcumin treatment results in better mouth opening versus Intralesional steroid.
3. Can Curcumin helps to improve tongue protrusion as compared to Intralesional steroids.

Participants will be:

* Assessed for one month, two month and three month.
* Burning Sensation will be assessed with visual analogue scale (VAS).
* Mouth Opening will be measured in mm with ruler.
* Tongue Protrusion will be assessed with the visual analogue scale (VAS).

Conditions

  • Oral Submucous Fibrosis

Interventions

DRUG

Curcumin (Turmeric)

Curcumin Capsule will be given two per day for three months. Patient Recovery progress will be monitored month on month basis for consecutive three month.

DRUG

Intralesional Steroid Injection

Intralesional Steroid Injection (1cc), one per week, will be administered in the fibrous bands wherever formed in the oral cavity. Patient recovery progress will be monitored on monthly basis for three months.

Sponsors & Collaborators

  • Services Institute of Medical Sciences, Pakistan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06758739 on ClinicalTrials.gov