A clinical trial to study the effects of Simvastatin on reduction in inflammation and improvement in functional status of patients with knee joint pains.
- Conditions
- Health Condition 1: null- Mild to moderate osteoarthritis
- Registration Number
- CTRI/2014/03/004469
- Lead Sponsor
- Indian Council of Medical Research New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Patients with American society of anesthesiologist (ASA) Iâ??II ,mild to moderate knee OA based on clinical history of knee pain with grade 1-3 of Kellgren-Lawrence radiological grading for OA and having at least one of the following:
Patient age 50-80 years
Morning stiffness lasting 30 minutes or less
Crepitus on motion
Patients receiving standard non pharmacological and medical treatment of OA since three months without any significant alterations.
Patient refusal
A body mass index (BMI) >40 kg/m2.
Patients who are receiving drugs that might interact with statins. Ciclosporins , Fibrates, Azol anti-fungals, Macrolide antibiotics, Antiarrhthymics(Verapamil, Amiodarone), Nefazodone ,Arotease inhibitors, anticoagulants ,tramadol and paracetamol combinations.
OA due to trauma, referred pain syndromes, septic/crystal arthritis and hemarthrosis and soft tissue conditions.
Patients with diabetes, serious medical condition, renal and hepatic disease, or deranged function tests.
Patients with existing pregnancy or breastfeeding.
Patients with Known hypersensitivity to Simvastatin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary aim of this study will be to evaluate effect of Simvastatin on Western Ontario and McMaster Universities WOMAC score in patients with mild to moderate knee OATimepoint: 03 years
- Secondary Outcome Measures
Name Time Method To study effect of simvastatin on inflammatory markers total consumption of analgesics number of acute pain events range of movements and any adverse events.Timepoint: 03 years