Evaluating Metformin for Knee Osteoarthritis
The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis
This study is testing if Metformin can help people aged 30 to 60 with knee osteoarthritis feel better and improve their joint function compared to another medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Damietta, New Damietta) |
| Trial ID | NCT06231758 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of Metformin in patients with knee osteoarthritis, a chronic condition that significantly impacts mobility and quality of life. Participants aged 30 to 60 with confirmed moderate to severe osteoarthritis will receive either Metformin or Celecoxib to assess improvements in symptoms and joint function. The study aims to provide insights into whether Metformin can alter the disease progression of osteoarthritis, which currently lacks effective long-term treatment options.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 60 with X-ray confirmed Kellgren-Lawrence grade II or III knee osteoarthritis.
Not a fit: Patients under 30 or over 60 years old, or those with inflammatory arthritis or other significant health issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option that may slow the progression of knee osteoarthritis and improve patient outcomes.
How similar studies have performed: While there have been studies exploring various treatments for osteoarthritis, the specific use of Metformin in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary osteoarthritis Patients recruited were between 30 to 60 years of age. * X-ray confirmed Kellgren-Lawrence grade II or III severity primary tibiofemoral OA according to the American College of Rheumatology criteria. Exclusion Criteria: Patients with age less than 30 years or more than 60 years Patients Presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug Patients Were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee Patients had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study Patients having a known hypersensitivity to the used medications Patients have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin\< 10.0 g/ dl or haematocrit \< 30%). Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.
Where this trial is running
Damietta, New Damietta
- Mostafa Bahaa — Damietta, New Damietta, Egypt (Recruiting)
Study contacts
- Study coordinator: Mostafa Bahaa
- Email: mbahaa@horus.edu.eg
- Phone: +201025538337
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.