- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04476420
Comparative Effect of Nigella Sativa and Conventional Management for OSMF
Comparison of Nigella Sativa Oil With Conventional Management on Clinical Outcomes in Oral Submucous Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75600
- Ziauddin University, Clifton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Investigators
- Principal Investigator: Hira Batool, Mphil, Ziauddin University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Stomatognathic Diseases
- Mouth Diseases
- Fibrosis
- Oral Submucous Fibrosis
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Betamethasone sodium phosphate
Other Study ID Numbers
- 2130520HBOM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Oral Submucous Fibrosis
-
The Oxford Dental College, Hospital and Research...CompletedOral SubMucous Fibrosis
-
Altamash Institute of Dental MedicineCompletedTumor | Pentoxifylline | Triamcinolone | Vitamin E | Oral Submucosa FibrosisPakistan
-
Ziauddin UniversityNot yet recruitingOral Submucous FibrosisPakistan
-
H.K.E.S's S.Nijalingappa Institute of Dental Science...Unknown
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Completed
-
The Oxford Dental College, Hospital and Research...Credora Life Sciences, IndiaCompletedOral Submucous Fibrosis
-
Government College of Dentistry, IndoreCompletedOral Submucous Fibrosis
-
SVS Institute of Dental SciencesUnknownOral Submucous FibrosisIndia
-
Sir Ganga Ram HospitalRecruiting
-
The University of Hong KongNot yet recruitingOral Cancer | Oral Leukoplakia | Erosive Lichen Planus | Oral Submucous Fibrosis | Proliferative Verrucous Leukoplakia | Oral Erythroplakia
Clinical Trials on Betamethasone Valerate
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedAtopic Eczema/Dermatitis (Non-Specific)United Kingdom
-
Cairo UniversityRecruitingRadiodermatitis; AcuteEgypt
-
ACO Hud Nordic ABCompleted
-
ACO Hud Nordic ABSmerud Medical Research International ASCompleted
-
LEO PharmaCompleted
-
GlaxoSmithKlineCompleted
-
Cairo UniversityNot yet recruitingLichen Simplex ChronicusEgypt
-
GlaxoSmithKlineCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
McMaster UniversityCompletedPregnancy Complications | Obstetric Labor Complications | Preterm Birth | Obstetric Labor, Premature | Complication of PrematurityCanada