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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Oral Submucous Fibrosis trials