Comparative Effect of Nigella Sativa and Conventional Management for OSMF

March 14, 2022 updated by: Hira Batool, Ziauddin University

Comparison of Nigella Sativa Oil With Conventional Management on Clinical Outcomes in Oral Submucous Fibrosis

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.

Study Overview

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 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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sindh
      • Karachi, Sindh, Pakistan, 75600
        • Ziauddin University, Clifton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Steroid group
Participants in group 1 will be given corticosteroid lotion (Betamethasone valerate 0.1%) and will be advised to apply it topically (0.5 ml) on the buccal mucosa thrice a day along with physiotherapy using ice cream sticks three times a day for the duration of 10 minutes (3-5minutes on each side).
it is a conventionally used drug for treating OSMF
Other Names:
  • Corticosteroid
Experimental: Nigella Sativa oil group
Group 2 will be given commercially available, cold pressed N.sativa (Black seed) oil and will be advised to apply it topically over the buccal mucosa (1 ml) thrice a day along with physiotherapy using ice cream sticks three times a day for the duration of 10 minutes (3-5minutes on each side).
Using N.sativa oil as an alternative to conventional management will help us to find a treatment option which is non-invasive, cost effective, inexpensive, easy available and belongs to a natural source with almost no side effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessed using visual analogue scale (VAS)
Time Frame: 6 months
Pain will be measured using VAS. This scale usually present as a 100-mm horizontal line on which the pain intensity experienced by the patient will be represented by a point between the extremes of "no pain at all" and "worst pain imaginable.
6 months
Inter-incisal mouth opening (IMO) assessed using vernier caliper
Time Frame: 6 months
Interincisal mouth opening will be calculated by measuring the distance between the mesioincisal angles of the maxillary central incisor and the mandibular central incisor with the help of a vernier calliper.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cheek Flexibility assessed following the method of Mathur and Jha (1993)
Time Frame: 6 months
A line will be drawn from the tragus of the ear to the angle of the mouth and then two reference points will be marked on both the cheeks at 1/3rd the distance from the angle of the mouth on the line drawn previously. After marking these reference points, the patient will be asked to blow his cheek and the distance will be measured between the two points. Then the patient will be instructed to relax his cheeks and the distance will be measured again. The difference between the two values will give the value for cheek flexibility.
6 months
Tongue protrusion
Time Frame: 6 months
Tongue protrusion will be recorded by measuring the distance between the tip of the tongue and the mesioincisal angle of the upper central incisor using steel ruler.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hira Batool, Mphil, Ziauddin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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