Knee Osteoarthritis Clinical Trial
Official title:
Effect of Metformin as Add-on Therapy to Ibuprofen on Disease Activity in Knee Osteoarthritis Patients: A Randomized Controlled Trial.
The goal of this randomized, double blind, placebo-controlled clinical trial is to learn about, the effect of metformin compared with placebo-controlled group on disease activity and interleukin-6 level in patients with knee osteoarthritis.The main question it aims to answer is:Is Metformin as add-on therapy more effective in reducing disease activity in Ibuprofen-treated patients with grade II-III knee osteoarthritis? Half of Participants will receive metformin with standard of care(ibuprofen and rabeprazole) while other half placebo and standard of care (ibuprofen and rabeprazole).
Status | Recruiting |
Enrollment | 68 |
Est. completion date | June 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Bangabandhu Sheikh Mujib Medical University | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. KOOS will be used to assess improvements in the scores(out of 100) of five patient-relevant outcomes (pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life) of knee osteoarthritis patients after 8 weeks of intervention. | 1 year | |
Secondary | Serum Interleukin-6 (IL-6) level | The reported values for IL-6 in the blood of healthy donors varied between 0 and 43.5 pg/ml.The pooled estimate of IL-6 was 5.186 pg/ml. IL-6 follows a circadian rhythm with a peak at the time of waking (04 am).Significantly higher levels of IL-6 are secreted from the Infrapatellar fat pad of knee OA patients and correlate with disease progression or severity of cartilage pathology. | 1 year |
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