Overview

Comparative Effect of Nigella Sativa and Conventional Management for OSMF

Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
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 jaws. OSMF has a multifactorial etiology but areca nut consumption is considered to be the most consistent factor in its pathogenesis. There is no definitive treatment available for treating OSMF. Conventional management involves physiotherapy exercises and treating the disease with certain medications such as steroids and homeopathic medications.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ziauddin University
Treatments:
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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