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Search / Trial NCT06126029

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

Launched by BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY, DHAKA, BANGLADESH · Nov 6, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding metformin, a medication commonly used to treat type 2 diabetes, can help reduce knee pain and improve disease activity in patients who are already taking ibuprofen for knee osteoarthritis. Osteoarthritis is a condition that causes pain and stiffness in the joints. The study will compare the effects of metformin with a placebo (a "sugar pill" that has no active ingredients) alongside standard treatments. Participants will be randomly assigned to receive either metformin or the placebo while continuing their ibuprofen treatment.

To be eligible for the trial, participants need to be between 18 and 65 years old, have knee pain, and show signs of knee osteoarthritis on X-rays. However, individuals with certain health conditions, such as diabetes, kidney problems, or recent knee surgeries, will not be able to participate. If you join the study, you can expect regular check-ups and support from the research team while helping to determine if metformin could be an effective addition to existing osteoarthritis treatments. This trial is currently recruiting participants, and everyone who is interested will need to give their consent to join.

Gender

ALL

Eligibility 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

About Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka, Bangladesh, is a premier institution dedicated to advancing medical education, research, and healthcare services. As a leading clinical trial sponsor, BSMMU is committed to fostering innovative research initiatives that enhance patient care and contribute to the global medical community. The university boasts a multidisciplinary team of experts and state-of-the-art facilities, enabling the conduct of rigorous clinical trials across various therapeutic areas. With a focus on ethical standards and patient safety, BSMMU aims to facilitate the development of new treatments and improve health outcomes both locally and internationally.

Locations

Dhaka, , Bangladesh

Dhaka, , Bangladesh

Patients applied

0 patients applied

Trial Officials

Md.Delowar Hossain, MD

Principal Investigator

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported