Osteoarthritis of knee Musculoskeletal Diseases Osteoarthritis
Conditions
Interventions
75 subjects randomised into 3 groups (n = 25):
1. 5-Loxin® 2 x 50 mg/day twice daily (bid)
2. 5-Loxin® 2 x 125 mg/day (bid)
3. Placebo
Ibuprofen was used as a rescue medication for all groups. The s
Sponsors
Laila Impex R&D Center (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must understand risks and benefits of the protocol and able to give informed consent 2. Male and female subjects of 40 - 80 years of age 3. Females of child bearing potential must agree to use an approved form of birth control and have a negative pregnancy test result 4. Unilateral or bilateral OA of the knee for more than 3 months 5. Visual Analogue Scale (VAS) score during the most painful knee movement between 40 - 70 mm after 7 day withdrawal of usual medication 6. Lequesne's functional index score greater than 7 points after 7 days of withdrawal of usual medication 7. Ability to walk 8. Availability of the duration of the entire study period
Exclusion criteria
Exclusion criteria: 1. History of underlying inflammatory arthropathy or severe Rheumatoid Arthritis (RA) 2. Hyperuricemia (greater than 440 umol/L) and/or past history of gout 3. Recent injury in the area affected by OA of the knee (past 4 months) and expectation of surgery in the next 4 months 4. Intra-articular corticosteroid injections within the last 3 months 5. Hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), abnormal liver or kidney function tests, history of peptic ulceration and upper Gastrointestinal (GI) haemorrhage, congestive heart failure, hypertension, hyperkalemia 6. Major abnormal findings on complete blood count, history of coagulopathies, haematological or neurological disorders 7. High alcohol intake (greater than 2 standard drinks per day) 8. Pregnant, breastfeeding or planning to become pregnant during the study 9. Use of concomitant prohibited medication other than ibuprofen 10. Obesity: Body Mass Index (BMI) less than 30 11. Systemic Lupus Erythematosis (SLE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Visual Analog Scale (VAS) 2. Lequesne Functional Index (LFI) 3. Western Ontario and McMaster Universities osteoarthritis index (WOMAC)-pain, WOMAC-stiffness and WOMAC-physical ability All primary and secondary outcomes are measured at baseline, 7, 30, 60 and 90 days of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. TNF-alpha 2. IL-1-beta 3. Interleukin-6 (IL-6) 4. C-Reactive Protein (CRP) 5. Matrix Metelloproteinase-3 (MMP-3) All primary and secondary outcomes are measured at baseline, 7, 30, 60 and 90 days of the study. | — |
Countries
India
Outcome results
None listed