Exploring the Fibrosis-Modulating Potential of Metformin and Pirfenidone in Oral Submucous Fibrosis: Molecular Mechanisms to Clinical Applications

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The goal of this clinical trial is to learn if metformin and antifibrotic drugs (pirfenidone) can modulate fibrosis and improve treatment outcomes in patients with oral submucous fibrosis (OSF). The study also aims to investigate the molecular mechanisms underlying their effects on exosome secretion and protein expression. The main questions it aims to answer are: Do metformin and antifibrotic drugs alter exosome secretion and biological activity in OSF cell lines? What molecular pathways are influenced by these drugs in modulating fibrosis? Does treatment with metformin and antifibrotic drugs improve clinical outcomes in OSF patients? Researchers will compare metformin and antifibrotic drug treatment groups to a control group to see if these drugs lead to significant changes in fibrosis-related exosomal protein expression and clinical improvement in OSF patients. Participants will : Undergo in vitro experiments on OSF cell lines to analyze drug effects using qPCR, Western Blot, and LCMS for protein profiling. Participate in a randomized, double-blind clinical trial where they receive metformin, antifibrotic drugs, or a placebo. Undergo clinical evaluations and laboratory tests to assess treatment efficacy. This study aims to develop an affordable and effective fibrosis-targeted therapy for OSF by repurposing metformin, potentially improving patient outcomes and reducing the risk of malignant transformation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Patients with OSF having fibrous bands

• Patients with limited mouth opening due to OSF in Stage 2 and Stage 3

• Patients who have not received any treatment for OSF in the previous three months

• Patients with habits of pan, Chalia, Gutkha

• The age group between 18 and 45 years

Locations
Other Locations
Pakistan
Ziauddin University
RECRUITING
Karachi
Contact Information
Primary
AFIFA RAZI, BDS FCPS
afifa.razi@zu.edu.pk
+92 300 2247389
Backup
Shumaila Usman, PhD
shumaila.usman@zu.edu.pk
+92 336 1882779
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 45
Treatments
Active_comparator: Beclomaethasone and Vitamin E
Group 1 Control (Supportive Care): Beclomethasone mouthwash three times + Capsule vitamin E 400mg daily.
Experimental: Metformin + Supportive Care
Group 2 (Metformin + Supportive Care): Metformin: 500 mg twice daily + Beclomethasone mouthwash three times + Capsule vitamin E 400mg daily.
Experimental: Pirfenidone + Supportive Care
Group 3 (Pirfenidone + Supportive Care): Pirfenidone: 200 mg twice daily + Beclomethasone mouthwash three times + Capsule vitamin E 400mg daily.
Related Therapeutic Areas
Sponsors
Leads: Ziauddin University
Collaborators: University of Karachi

This content was sourced from clinicaltrials.gov