CompletedPhase 1/2

Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial

Pakistan30 participantsStarted 2024-08-12

Plain-language summary

OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition

Who can participate

Age range

18 Years – 45 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 OSF- palpable bands on oral examination
. Patients with limited mouth opening due to OSF
. Patients who have not received any treatment for OSF in the previous three months
. Patients with habits of pan, Chalia, Ghutka
. Age group between 18 and 45 years

Exclusion criteria

. Patients presenting with both OSCC and OSF
. Patients with limited mouth opening due to impaction of the third molar (impaction of third molar results in limited mouth opening hence such patients are excluded since limited mouth opening due to third molar impaction can be mistaken for OSF).

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

Cell Viability

Timeframe: 8 months

Cytotoxicity

Timeframe: 8 Months

Morphological Changes Cell Shape

Timeframe: 8months

Morphological Change Cell Density

Timeframe: 8 months

Morphological Change Extracellular Matrix (ECM) Structure

Timeframe: 8 months

Cell Migration Assays

Timeframe: 8months

Cell Invasion Assays

Timeframe: 8 months

Apoptosis Analysis

Timeframe: 8months

Trial details

NCT IDNCT06332612

SponsorZiauddin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Oral Submucous Fibrosis trials

Plain-language summary

Who can participate

Age range

18 Years – 45 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 OSF- palpable bands on oral examination
. Patients with limited mouth opening due to OSF
. Patients who have not received any treatment for OSF in the previous three months
. Patients with habits of pan, Chalia, Ghutka
. Age group between 18 and 45 years

Exclusion criteria

. Patients presenting with both OSCC and OSF
. Patients with limited mouth opening due to impaction of the third molar (impaction of third molar results in limited mouth opening hence such patients are excluded since limited mouth opening due to third molar impaction can be mistaken for OSF).

What they're measuring

Cell Viability

Timeframe: 8 months

Cytotoxicity

Timeframe: 8 Months

Morphological Changes Cell Shape

Timeframe: 8months

Morphological Change Cell Density

Timeframe: 8 months

Morphological Change Extracellular Matrix (ECM) Structure

Timeframe: 8 months

Cell Migration Assays

Timeframe: 8months

Cell Invasion Assays

Timeframe: 8 months

Apoptosis Analysis

Timeframe: 8months