Osteoarthritis. Osteoarthritis of knee
Conditions
Interventions
Intervention 1: Intervention group: metformin tablets (ingredients: microcrystalline cellulose, hydroxypropylmethylcellulose, magnesium stearate, and metformin hydrochloride) Kushan Pharmed company -
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who, based on the radiography and ACR criteria, have knee osteoarthritis grades 2 & 3 according to the Kellgren and Lawrence criteria (Kellgren and Lawrence grade 2, the presence of osteophytes and joint space narrowing & grade 3 confirming the presence of more numbers of sclerosis and osteophyte). 50 to 75 years olds Man or woman BMI body mass index (=24 kg/m2) VAS Knee pain score= 2 on 10 Primary Osteoarthritis (not secondary OA due to trauma or inflammatory arthritis) The person is willing and able to follow the study instructions and go to the clinic for a visit No history of performing knee arthroscopy and injecting corticosteroids in the knee within less than 6 months from the beginning of the study No allergy to any of the compounds used in the study No history of severe trauma in the knee area No history of other rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis and others No active malignancy, cancer or other life-destructive diseases and Type 1 or type 2 diabetes mellitus, hypoxic conditions (corpulmonary-congestive heart failure-acute MI-peripheral artery disease), uncontrolled high blood pressure No Clinical manifestation of liver dysfunction or elevated alanine aminotransferase/aspartate ami- notransferase levels exceeding 2 times the upper limit of normal values GFR glomerular filtration rate higher than ml/min/1.73m2-60 No history of systemic corticosteroids using Not using of alcoholic substances No history of Conditions affecting the absorption of oral drugs (e.g., post gastrectomy and malabsorption syndrome) No history of using metformin in the last 30 days
Exclusion criteria
Exclusion criteria: Injecting of corticosteroids in the knee within the study Estimated glomerular filtration rate of less than 60 ml/min/1.73 m2; Allergic to metformin hydrochloride; Severe knee trauma during study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC INDEX of osteoarthritis. Timepoint: evaluation of WOMAC index before the study and 4 month later. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Visual Analogue Scale (VAS) pain score. Timepoint: before the start of the intervention and four consecutive month after the start of the intervention. Method of measurement: The Visual Analogue Scale (VAS) pain score 0-10. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Maryam Kiani
Mashhad University of Medical Sciences
Outcome results
None listed