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Clinical Trials/CTRI/2015/04/005696
CTRI/2015/04/005696
Recruiting
Phase 4

A Randomised control trial of the Corticosteroids in OSF.

none0 sites60 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Oral Submucous Fibrosis
Sponsor
none
Enrollment
60
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
none

Eligibility Criteria

Inclusion Criteria

  • 1\.Patients with burning sensation of the oral cavity (either on eating hot and spicy food or on eating regular food)
  • 2\.Limited opening of the mouth.
  • 3\.Fibrosis of the oral cavity.
  • 4\.A positive history of current consumption of areca nut products
  • 5\.Histopathological report of OSF

Exclusion Criteria

  • 1\.History of any medical illness or systemic disease like diabetes, hypertension, multiple allergies etc.
  • 2\.Patients undergoing any immunotherapy or active treatment for OSF or had undergone treatment for OSF within the last three months.
  • 3\.Mouth opening less than 15mms or greater than 45 mm.
  • 4\.Pregnant or lactating patients or patients intending on becoming pregnant in the next six months.
  • 5\.Patients who had used steroid harmone based contraceptive in last one month.

Outcomes

Primary Outcomes

Not specified

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