Effects of Metformin and Pirfenidone on Oral Submucous Fibrosis
Exploring the Fibrosis-Modulating Potential of Metformin and Pirfenidone in Oral Submucous Fibrosis: Molecular Mechanisms to Clinical Applications
This study is testing if the medications metformin and pirfenidone can help people with oral submucous fibrosis feel better by reducing symptoms and improving treatment results.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Ziauddin University Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06871904 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether metformin and the antifibrotic drug pirfenidone can modulate fibrosis and improve treatment outcomes in patients with oral submucous fibrosis (OSF). The study will analyze the effects of these drugs on exosome secretion and protein expression in OSF cell lines through in vitro experiments, employing techniques such as qPCR and Western Blot. Additionally, it aims to compare the clinical outcomes of patients receiving these treatments against a control group to assess their efficacy in reducing fibrosis-related symptoms. The research seeks to uncover the molecular pathways influenced by these drugs, providing insights into their potential therapeutic benefits.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 45 with oral submucous fibrosis exhibiting fibrous bands and limited mouth opening.
Not a fit: Patients with oral squamous cell carcinoma or those with contraindications to metformin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and affordable treatment options for patients suffering from oral submucous fibrosis.
How similar studies have performed: While the specific combination of metformin and pirfenidone in this context is novel, previous studies have shown promise in using antifibrotic agents for similar conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Karachi, Sindh
- Ziauddin University — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Study coordinator: Afifa Razi, Bds Fcps
- Email: afifa.razi@zu.edu.pk
- Phone: +92 300 2247389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.