Status:

COMPLETED

Comparative Effect of Nigella Sativa and Conventional Management for OSMF

Lead Sponsor:

Ziauddin University

Conditions:

Oral Submucous Fibrosis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Oral submucous fibrosis (OSMF) is a potentially malignant condition mainly characterized by inflammation and fibrosis of the submucosal tissues leading to marked rigidity and reduced opening of the ja...

Detailed Description

OSMF is a chronic insidious disorder of the oral cavity which has a great potential to turn malignant. The clinical manifestations of OSMF comprise of white, marble-like appearance of the oral mucosa ...

Eligibility Criteria

Inclusion

  • Patients with the age of 18 years and above
  • Patients clinically diagnosed with Oral submucous fibrosis
  • Patients who have not received any treatment for Oral submucous fibrosis in the last three months.
  • Patients who are willing to quit the habit of eating pan, gutka and areca nut
  • Patients who are willing to attend the follow up visits

Exclusion

  • Patients who are less than 18 years of age
  • Patients who are already using pain medications, corticosteroids or immunosuppressive drugs in any other form
  • Patients with a history of malignancy
  • Patients presenting with oral lesions other than Oral submucous fibrosis (OSMF)
  • Patients who are allergic to the drug material used in the clinical trial
  • Patients who will not give consent

Key Trial Info

Start Date :

February 11 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2021

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT04476420

Start Date

February 11 2021

End Date

September 30 2021

Last Update

March 15 2022

Active Locations (1)

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1

Ziauddin University, Clifton

Karachi, Sindh, Pakistan, 75600