Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: METFORMIN DRUG: Oral Metformin (500 mg) twice daily after meals (breakfast and dinner)for a total duration of 4 weeks.
Control Intervention1: placebo tablets 500 mg tablets: Placebo cal
Sponsors
D.Y. PATIL Deemed to be University School of Medicine, Navi Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 30 to 70 years. 2. Clinically diagnosed and radiologically confirmed mild to moderate (Kellgren Lawrence grade II and III) symptomatic cases of Osteoarthritis of the knee joints. 3. Onset of symptom duration greater than or equal to 6 months at the time of screening. 4. Greater than or equal to 5 score on a 10-point visual analogue scale (VAS) for pain at baseline. 5. Willing to give consent for participating in the study.
Exclusion criteria
Exclusion criteria: 1. Patients having severe (Kellgren lawrence grade IV)/ disabling arthritis in the targeted or contralateral knee joint. 2. Patients with radiologically abnormal knee alignment. 3. Those who are suffering from skin-related problems at the local sites of drug application, which may be affected the drug application. 4. Patients with a history of Chikungunya, Dengue, or other viral infections in the past six months. 5. Participants with a history or presence of Type 1 and Type 2 diabetes. 6. Those who are on treatment with immunosuppressive drugs and biologicals 7. Participants who are taking any other oral hypoglycaemic drugs. 8.Participants who are taking metformin for any other indication. 9. Participants who are prone to gastrointestinal symptoms like nausea, vomiting, diarrhea, and flatulence Vitamin B12 deficiency. 10. Pregnant and lactating women 11. Any condition which, in the opinion of investigator, will place the subject at risk or will influence the conduct of study or interpretation of results 12. Diagnosed cases of Rheumatoid arthritis (RA factor positive) and Gouty arthritis (Serum Uric acid greater than UNL) 13. Patient requiring any systemic analgesic for other conditions that can affect the outcome of the study drug 14.Patient on systemic corticosteroid therapy 15. Known case of history of allergy with NSAIDs or test drug. 16.Patients with BMI greater than or equal to 40 kg/m2. 17. Participants who have enrolled in any other trial in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain severity from baseline, measured using the pain subscale of the Oxford Knee Score (OKS), in participants with mild to moderate knee osteoarthritis receiving the intervention.Timepoint: Pain assessment using OKS at Week 1, Week 2, Week 3, and Week 4 following initiation of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in range of motion (ROM) of the affected knee joint from baseline, measured using goniometry. Change in pain intensity from baseline, assessed using the 10-point Visual Analogue Scale (VAS). Change in Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline, reflecting improvements in pain, symptoms, function, & quality of life. Frequency & quantity of rescue analgesic use, indicating additional pain management needs. Incidence of adverse events (AEs), treatment-emergent adverse events (TEAEs), & serious adverse events (SAEs) during the study period.Timepoint: Week 1, Week 2, Week 3, & Week 4 post-initiation of intervention for all secondary outcomes listed above. | — |
Countries
India
Contacts
Public ContactDr Adwait Malik
DY Patil deemed to be University School of Medicine, Navi Mumbai
Outcome results
None listed