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

NCT06126029 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-11-14

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Metformin 500 Mg extended release Oral Tablet

34 patients of experimental group will get metformin 500mg extended release oral tablet once daily with evening meal along with standard of care (ibuprofen 400mg and rabeprazole 20mg twice daily) for 8 weeks as prescribed by the physician.

DRUG

Placebo oral tablet

34 patients of placebo group will get placebo oral tablet once daily with evening meal along with standard of care (ibuprofen 400mg and rabeprazole 20mg twice daily) for 8 weeks as prescribed by the physician.

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Md.Delowar Hossain, MD · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-04-30
Completion
2024-06-30

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126029 on ClinicalTrials.gov