CompletedPhase 3

Comparative Effect of Nigella Sativa and Conventional Management for OSMF

Pakistan39 participantsStarted 2021-02-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pain assessed using visual analogue scale (VAS)

Timeframe: 6 months

Inter-incisal mouth opening (IMO) assessed using vernier caliper

Timeframe: 6 months

Trial details

NCT IDNCT04476420

SponsorZiauddin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30