Comparative Effect of Nigella Sativa and Conventional Management for OSMF

NCT04476420 | Completed Phase 3 DMC

• 1 other identifier: 2130520HBOM
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Oral Submucous Fibrosis

Keywords

OSMF

Outcome Measures

Primary Outcomes (2)

• Pain assessed using visual analogue scale (VAS)

  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

  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 Outcomes (2)

• Cheek Flexibility assessed following the method of Mathur and Jha (1993)

  6 months

• Tongue protrusion

  6 months

Study Arms (2)

Steroid group

ACTIVE COMPARATOR

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).

Drug: Betamethasone Valerate

Nigella Sativa oil group

EXPERIMENTAL

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).

Dietary Supplement: Nigella sativa oil

Interventions

Nigella sativa oil DIETARY_SUPPLEMENT

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.

Nigella Sativa oil group

Betamethasone Valerate DRUG

it is a conventionally used drug for treating OSMF

Also known as: Corticosteroid

Steroid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University, Clifton

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Oral Submucous Fibrosis

Interventions

Nigella sativa oil; Betamethasone Valerate; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Hira Batool, Mphil

  Ziauddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 20, 2020
• Study Start: February 11, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)