Using Metformin with Ibuprofen to Treat Knee Osteoarthritis
Effect of Metformin as Add-on Therapy to Ibuprofen on Disease Activity in Knee Osteoarthritis Patients: A Randomized Controlled Trial.
This study is testing if adding metformin to ibuprofen can help people with knee osteoarthritis feel better and improve their condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06126029 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of metformin as an add-on therapy to ibuprofen in patients with knee osteoarthritis. It is a randomized, double-blind, placebo-controlled study where participants will receive either metformin or a placebo alongside standard care. The primary focus is to assess the impact of metformin on disease activity and interleukin-6 levels in individuals with grade II-III knee osteoarthritis. The trial aims to provide insights into whether metformin can enhance the treatment outcomes for patients already receiving ibuprofen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with knee pain and radiographic evidence of grade II-III knee osteoarthritis.
Not a fit: Patients with diabetes, systemic inflammatory conditions, or those who have recently undergone knee surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of knee osteoarthritis symptoms and enhanced quality of life for patients.
How similar studies have performed: While the combination of metformin with ibuprofen is a novel approach, previous studies have shown potential benefits of metformin in inflammatory conditions, suggesting a promising avenue for exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with knee pain * Radiographic evidence of knee osteoarthritis (Grade II-III) * Age 18-65 years * Both male and female * Normal BMI(for asians): 18.5-22.9 kg/m2 Exclusion Criteria: * Diagnosed case of Diabetes Mellitus, renal, hepatic, cardiovascular or pulmonary disease * Diagnosed case of Gout or pseudogout * Diagnosed case of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease * Patients currently receiving immunosuppressant, carbonic anhydrase inhibitors(topiramate), ranolazine, vandetanib, dolutegravir * History of receiving a corticosteroid injection in the last three months * Prior history of knee trauma or surgery * Metformin use or history of use in the last two months * Known allergy to metformin * History of lactic acidosis * Patient with habit of excessive alcohol intake * Pregnancy * Patients unwilling to participate or unwilling to give written consent * Participation in another clinical trial
Where this trial is running
Dhaka
- Bangabandhu Sheikh Mujib Medical University — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Md.Delowar Hossain, MD — Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study coordinator: Md.Delowar Hossain, MD
- Email: delowar650@gmail.com
- Phone: +8801675369860
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.