Effect of Metformin as Add-on Therapy to Ibuprofen on Disease Activity in Knee Osteoarthritis Patients.

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Metformin

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