Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Metformin with standard therapy: Standard therapy with Tab metformin 500 mg once a day in the evening with meals for 6 weeks, then increased to 500mg twice a day for the rest 6 months.
Sponsors
Pandit B.D. Sharma UHS Rohtak
Eligibility
Inclusion criteria
Inclusion criteria: Either gender with age 40 years and above. Confirmed diagnosis of knee osteoarthritis according to criteria established by American College of Rheumatology (ACR). Mild to moderate knee OA detected on x-ray knee joint (Kellgren Lawrence grade 2 & 3). BMI greater than 25 kg/m . Subjects willing to participate and give informed consent for the study.
Exclusion criteria
Exclusion criteria: Presence of other metabolic or systemic conditions which could confound the results. For e.g. Type 2 diabetes, Cardiovascular diseases, inflammatory rheumatic diseases. Patients already taking metformin due to any other indication. Patients having hepatic impairement (1.5 fold increase in liver enzymes) or renal impairement (eGFR less than 30mL/min/1.73m2). Patients who have undergone any surgical intervention in index knee in the past year and planned in next 6 months. H/o known allergy to study drug. Acute or chronic metabolic acidosis. Intra-articular hyaluronic acid injection & corticosteroid injections within past 3 months. Conditions affecting lower limb function e.g., neurological disorders like stroke. Patients with significant comorbidities such as malignancy. Patients with significant knee injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess change in the intensity of pain in knee by using 100mm Visual Analogue Scale (VAS) at 3 & 6 months as compared to baseline in both the groupsTimepoint: Baseline, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in the stiffness, functional limitations and physical activity & mobility in knee by using Visual Analog Scale (VAS) at 3 and 6 months as compared to baseline in both the groupsTimepoint: Baseline, 3 and 6 months;To assess the change in thickness of articular cartilage and synovial membrane, joint effusion, growth of osteophytes and meniscal tear by ultrasound (USG) of knee at 6 months as compared to baseline in both the groupsTimepoint: Baseline and 6 months;To assess overall response in knee osteoarthritis by Physician Global Assessment (PGA) scale at 3 & 6 months as compared to baseline in both the groupsTimepoint: Baseline, 3 and 6 months;To assess the change in intensity of pain, stiffness, function and quality of life (QOL) in knee by using Knee Osteoarthritis Outcome Score (KOOS) at 3 & 6 months as compared to baseline in both the groupsTimepoint: Baseline, 3 and 6 months;To assess the safety in both the groups by monitoring adverse drug reactions throughout the studyTimepoint: Throughout the study period;To assess treatment adherence of patients during 6 weekly follow-up clinic visits and telephonically at 2 weekly interval Timepoint: 2 weekly telephonically and 6 weekly follow up visits | — |
Countries
India
Contacts
Public ContactDr Raghav Aggarwal
Pandit B.D. Sharma, PGIMS, Rohtak
Outcome results
None listed