Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04476420 |
Other study ID # |
2130520HBOM |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
February 11, 2021 |
Est. completion date |
September 30, 2021 |
Study information
Verified date |
March 2022 |
Source |
Ziauddin University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 with loss of flexibility and formation of palpable fibrous bands extending
from the anterior to the posterior region of the oral cavity.Other features include burning
sensation on taking spicy food, loss of papillae of the tongue, loss of natural pigmentation
of the lips and restricted mouth opening.
There is no definitive treatment available for OSMF due to its complex etiology. The most
essential component in the management of OSMF is the discontinuation of the habit of areca
nut chewing by the patient followed by conservative or surgical treatment. Currently,
steroids are the most commonly used drug group in managing OSMF because of their ability to
reduce the inflammatory process and increasing the apoptosis of inflammatory cells thereby
decreasing fibrosis. However, they are not very useful in reversing the pathology and
restoring mucosal elasticity and can cause mucosal thinning with long term use ultimately
resulting in worsening of the symptoms of the disease.
Many in- vitro and in- vivo studies have been conducted to establish the anti neoplastic,
anti inflammatory, immunomodulatory, antihypertensive, antimicrobial, anti-parasitic,
antioxidant and hypoglycemic properties of N.sativa oil. Among all the constituents of
Nigella sativa, Thymoquinone (Tq) is the most pharmacologically active constituent
responsible for most of its properties. Nigella sativa has been used widely in different food
preparations in the form of a flavoring agent or a spice. It is also recognized as 'safe' in
the inventory of United States Food and Drug administration.