Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis

Launched by ZIAUDDIN UNIVERSITY · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the potential benefits of two medications, metformin and pirfenidone, for patients with a condition called oral submucous fibrosis (OSF). OSF causes thickening and stiffening of tissues in the mouth, making it difficult to open the mouth. The researchers want to find out if these drugs can help reduce this stiffness and improve patients’ symptoms. They will study how these medications affect certain proteins and tiny particles called exosomes in cells related to OSF, and they will compare the results of those treated with the medications to those who receive a placebo (a harmless pill with no active ingredients).

To participate in the trial, individuals must be between 18 and 45 years old and have specific symptoms of OSF, such as fibrous bands and limited mouth opening. They should not have received any OSF treatment in the last three months or have certain other medical conditions. Participants will be randomly assigned to receive either metformin, pirfenidone, or a placebo, and they will undergo various tests to see how well the treatments work. The ultimate goal is to develop a safe and effective way to treat OSF, which could lead to better outcomes for patients and lower the chances of this condition leading to more serious health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with OSF having fibrous bands
• • 2. Patients with limited mouth opening due to OSF in Stage 2 and Stage 3
• • 3. Patients who have not received any treatment for OSF in the previous three months
• • 4. Patients with habits of pan, Chalia, Gutkha
• • 5. The age group between 18 and 45 years
• Exclusion Criteria:
• • 1. Patients presenting with OSCC
• • 2. Patients with limited mouth opening due to impaction of the third molar
• • 3. Patients with limited mouth opening due to temporomandibular joint disorder
• • 4. Any history of Metformin intolerance or contraindications to its use.
• • 5. Medical conditions (e.g., cardiovascular disease, renal/hepatic impairment) or drug therapy (\>6 months) with immunosuppressants, corticosteroids, or antifibrotics.
• • 6. Pregnancy or lactation.
• • 7. Participation in other clinical trials concurrently.
• • 8. Inability / unwilling to provide informed written consent.